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  7. Ventilators and Ventilator Accessories EUAs
  1. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

Ventilators and Ventilator Accessories EUAs

A continuous ventilator is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. FDA has issued EUAs to help increase the availability of ventilators and ventilator accessories, which are integral to treat patients with severe respiratory distress during the COVID-19 pandemic.

Umbrella EUA for Ventilators and Ventilator Accessories

On March 24, 2020, FDA issued an umbrella EUA in response to concerns about the insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 pandemic. This EUA authorizes the emergency use of certain ventilators, anesthesia gas machines modified for use as ventilators, positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories that the FDA determines meet specified criteria for safety, performance, and labeling. The devices that are eligible for inclusion under the EUA are those that are not currently marketed in the U.S., or those that are currently marketed in the U.S. but a modification is made to the device that would trigger the requirement that a manufacturer submit a new premarket notification (510(k)) to the FDA, as discussed in the agency's Ventilator Enforcement Policy. See FAQs on Ventilators for more information.

The scope of this authorization is limited to the use of ventilators, ventilator tubing connectors, and ventilator accessories listed below in Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories for use in healthcare settings by patients during the COVID-19 pandemic.

For Ventilator EUA: The interactive review template, which can be used to provide information to FDA, to support inclusion of an eligible product under the Ventilator EUA is available: Ventilator EUA Interactive Review Template (Updated April 21, 2020)

The tables below lists the ventilators, ventilator tubing connectors, and ventilator accessories authorized in this umbrella EUA.


Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories (Updated July 8, 2020)

The table below includes a list of authorized ventilator, ventilator tubing connector, and ventilator accessory to the list of authorized products in this Umbrella EUA during the COVID-19 public health emergency.


Authorized Ventilators

Date of Authorization Manufacturer Product Name Device Description Intended Use
03/25/2020 Beijing Aeonmed Co., Ltd VG70 ventilator Critical Care Ventilator Mechanical ventilation of patients in ICU
03/28/2020 Shenzen Mindray Bio-medical Electronics Mindray SV300/SV600/SV800 ventilators Critical Care Ventilator This product is intended to provide ventilation assistance and breathing support for adult,
pediatric and infant patients
03/28/2020 Vyaire Medical, Inc. LTV2 model 2200 and LTV model 2150 Critical Care Ventilator LTV2 model 2200 and 2150 ventilators are intended to provide continuous or intermittent ventilatory support for the care of the individuals who require mechanical ventilation. The use environment is for institutional use. Institutional use includes ICU or other hospital environments including intra-hospital transport. The Model 2200 can operate with high O2. The Model 2150 operates with low pressure.
03/30/2020 RESMED Stellar 150 Ventilator, Continuous, Minimal Ventilatory Support, Facility Use The Stellar 150 is intended to provide ventilation for non-dependent, spontaneously breathing adult and pediatric patients (30 lb/13 kg and above) with respiratory insufficiency, or respiratory failure, with or without obstructive sleep apnea. The device is for noninvasive use, or invasive use (with the use of the ResMed Leak Valve).
The iVAPS mode with optional AutoEPAP is intended for patients weighing more than 66lb (30kg). Operation of the device includes both stationary, such as in hospital or home, or mobile, such as wheelchair usage
03/30/2020 RESMED Lumis 150 VPAP ST (Amended
April 17, 2020)
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use The ResMed Lumis 150 VPAP ST devices are indicated to provide non-invasive ventilation for patients weighing more than 30 lbs (13 kg), or more than 66 lbs (30kg) in iVAPS mode, with respiratory insufficiency or obstructive sleep apnea (OSA). They are intended for home and hospital use. The ResMed Lumis 150 VPAP ST devices can be used with an attachable humidifier that is intended for single patient use in the home environment and re-use in a hospital/institutional environment.
03/31/2020 RESMED GA ST Ventilator, Continuous, Minimal Ventilatory Support, Facility Use The GA non-invasive ventilator is an assist ventilator and is intended to augment patient breathing. It is intended solely for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The ventilator is intended to support patients weighing 20 kg (44 lb) or greater. The ventilator is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.
03/31/2020 RESMED Flexo Bi-Level ST Ventilator, Continuous, Minimal Ventilatory Support, Facility Use Flexo Bi-level positive airway pressure therapy device is used to provide non‐invasive ventilatory support of mechanical ventilation for: Patients who are independent and spontaneously breathing, Patients with respiratory insufficiency and sleeping breathing disorders. It can provide both a stable continuous positive airway pressure and a bi‐level positive airway pressure. It is not a life support ventilator. It is intended to be used in the home or professional medical environment. The therapeutic pressure is prescribed by a physician according to patients' condition.
03/31/2020 RESMED AirCurve
S T(Amended
April 17, 2020)
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use AirCurve ST device has indications for use that include respiratory insufficiency. The AirCurve ST device is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (30kg). It is intended for home and hospital use.
03/31/2020 Amsino YUWELL®
YH-730 Bi-level PAP and YH-830 Bi-level PAP
Ventilator, Non-Continuous The Bi-level device is indicated for treatment of sleep apnea hypopnea syndrome in patients weighing more than 66lb (30kg). It is intended both for home use and hospital use. The water tank is intended for single patient use in the home environment and re-use in a hospital/institutional environment.
03/31/2020 Inovytec Ventway Sparrow Ventilator, Continuous The Ventway Sparrow ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg (11 lb), who require the following types of ventilatory support: SIMV - VC (PS), CPAP. The Ventway Sparrow lung ventilator is intended for emergency use and during transportation. It may be used for invasive or non-invasive ventilation presets. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician.
04/01/2020 Philips Respironics VX850 Ventilator Critical Care Ventilator The VX850 ventilator is intended to provide continuous or intermittent respiratory support and monitoring of pediatric and adult patients. The VX850 is intended to be used in a hospital or other institutional healthcare environment and is intended for intra-facility transport. The VX850 ventilator is intended for use by qualified, trained personnel under direction of a physician. The VX850 is intended for use with pediatric (infants) ages 2 months to 2 years and weighing 5 kg or greater, up to and including adult patients.
04/02/2020 BMC Medical CO., LTD Luna G3 BPAP 25A- LG3700 Ventilator, Continuous, Minimal Ventilatory Support, Facility Use The G3 B25A BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide non-invasive ventilation for patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. These devices are intended for adult patients by prescription in the home or hospital/institutional environment.
04/02/2020 BMC Medical Co., Ltd. Y-30T Ventilator, Continuous, Minimal Ventilatory Support, Facility Use BPAP System (Y-30T Model) is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide non-invasive ventilation for patients with obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. Y-30T device is intended for adult patient by prescription in the home or hospital/institutional environment. This device is not intended for life support. The optional Heated Humidifier used with the Y-30T device together is indicated for taking humidifying and heating air from the device.
04/02/2020 Dragerwerk AG & CO. KGaA Evita V800 and Evita V600 Critical Care Ventilator The intensive care Ventilator Evita is intended for the Ventilation of adults, adolescents, children, infants and neonates. This device provides mandatory Ventilation modes and Ventilation modes for supporting spontaneous breathing as well as Ventilation monitoring
04/03/2020 Dragerwerk AG & CO. KGaA Babylog VN800 and VN600 Critical Care Ventilator The intensive care ventilator Babylog is intended for the ventilation of neonates from 0.4 kg (0.88 lb) up to 10 kg (22 lb), and pediatric patients from 5 kg (11 lb) up to 20 kg (44lb) bodyweight. This device provides mandatory ventilation modes and ventilation modes for supporting spontaneous breathing as well as ventilation monitoring.
04/03/2020 GE Healthcare pNeuton Model A-E Ventilator Ventilator, Continuous, Facility Use

The pNeuton Ventilator is intended for continuous mechanical ventilation of patients in the following patient populations and use locations: Patient population - adult / pediatric patients 23 Kg and greater who require the following general types of ventilatory support:

  • positive pressure ventilation delivered invasively (via an ET tube) or non-invasively (via a mask)
  • CMV and IMV modes of ventilation
  • with or without PEEP / CPAP
  • with oxygen or a mixture of air and oxygen The ventilator is suitable for use in:
  • Hospitals and alternate care units to meet the needs for mechanical ventilation
  • Pre-hospital transport applications including accident scene, emergency rescue vehicles
  • Hospital ICU transport applications including emergency, radiology, surgery and post anesthesia/recovery
  • Air transport via helicopter or fixed wing
04/05/2020 Covidien LLC Puritan Bennett 560 Ventilator System Ventilator, Continuous,

The Puritan Bennett 560 Ventilator is indicated for the continuous or intermittent mechanical ventilatory support of patients weighing at least 11 lb (5 kg) who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a doctor. It is essential to read, understand, and follow these instructions before using the Puritan Bennett 560 Ventilator. Specifically, the ventilator is applicable for adult and pediatric patients who require the following general types of invasive or non-invasive ventilatory support, as prescribed by an attending doctor:

  • Positive Pressure ventilation
  • Assist/Control, SIMV, or CPAP modes of ventilation
  • Breath types including Volume Control, Pressure Control, and Pressure Support The ventilator is suitable for use in institutional, home, and portable settings. It is not intended for use in Emergency Medical Service (EMS) such as an emergency transport.
04/06/2020 CoLabs COVID Ventor Emergency Ventilator The COVID Ventor system is an emergency use ventilator used to provide adult patients with emergency ventilatory support when no alternative FDA-approved ventilators are available. The COVID Ventor System consists of the reusable Ventor Console (Console) and the single use, disposable Ventor-Specific Breathing Circuit (Breathing Circuit). The COVID Ventor is able to provide Pressure Controlled, Pressure Supported, and Volume Controlled long-term ventilatory support in emergency situations
04/06/2020 MEKICS Co,. Ltd MTV1000 ventilator Ventilator, Continuous MTV1000 ventilator is designed for use on patient population sizes from pediatric through adult who require respiratory support or mechanical ventilation and weigh a minimum of 5.0 kg. It is suitable for service in hospitals to provide continuous positive pressure ventilatory support using medical oxygen and compressed medical air from internal air sources to deliver oxygen concentrations of 21 % to 100 %. Ventilatory support can be delivered invasively or noninvasive.
04/07/2020 Drägerwerk AG & Co. KGaA Atlan A350 and Atlan A350 XL Gas-Machine, Anesthesia

This device is intended for use in anesthetizing adults, pediatric patients, and neonates. The device can be used for mechanical ventilation, manual ventilation,
pressure-supported spontaneous breathing, and spontaneous breathing. The device is equipped with the following basic functions:

  • Ventilation monitoring
  • Inspiratory O2 measurement
  • Device monitoring
  • Anesthetic gas receiving system

The following options are additionally available:

  • Patient-gas measurement module for O2, CO2, N2O, and anesthetic gases
  • O2 insufflation

Anesthesia is achieved through a mixture of pure oxygen and Air (medical compressed air) or pure oxygen and nitrous oxide, with the addition of volatile
anesthetic agents. Ventilation is accomplished on the patient through a laryngeal mask, a breathing mask, or an endotracheal tube. The integrated breathing system can be used with partial rebreathing (low-flow or minimum-flow).

04/07/2020 VenTec Life Systems V+Pro Emergency Ventilator Ventilator, Continuous VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non-invasive applications. VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional, and transport settings, including portable applications.
04/08/2020 AMBULANC TECH.CO.,LTD Models 6000S, T5, T7 Emergency Transport Ventilator

Model 6000S - The 6000S ventilator is intended to provide continuous ventilation for patients who require invasive or noninvasive respiratory support and weigh more than 15KG (Infants, children, adults). The 6000S ventilator offers IPPV (Intermittent Positive Pressure Ventilation Mode), AC (Assisted Control Ventilation Mode), CPR auxiliary modes, etc. The 6000S ventilator can display the monitoring pressure waveform and interface parameters (Pmax, Pmean) in real time. The 6000S Ventilator is intended for use in emergency treatment outside the hospital and in-hospital transportation, and it runs under the central oxygen supply of the hospital or an oxygen cylinder pressure greater than 2.7Bar.

Model T5 - The T5 ventilator is intended to provide continuous ventilation for patients who require invasive or noninvasive respiratory support (Infants, children, adults), with a tidal volume greater than 50ml. The T5 ventilator offers capacity control (IPPV, VAC, VSIMV), pressure control (PCV, PAC, PSIMV), noninvasive breathing (CPAP) modes, etc. It also has CPR auxiliary function and ETCO2 detection function. The T5 ventilator can display pressure waveform, ETCO2 waveform and parameters (pressure, tidal volume, ETCO2) in real time. The T5 ventilator is intended for use in out-of-hospital emergency treatment (first aid treatment on the ground, at sea, and in the air) and in-hospital transportation run under the central oxygen supply of the hospital or an oxygen cylinder pressure greater than 2.7Bar. Model T7 - The T7 ventilator is intended to provide continuous ventilation for patients with weight greater than 2kg (infants, children, adults) who require invasive or noninvasive respiratory support, with a tidal volume greater than 20ml. The T7 ventilator offers volume control (IPPV, VAC, VSIMV), pressure control (PCV, PAC, PSIMV), non-invasive (CPAP, CPAP + PSV, BiPPV, APRV), advanced ventilation (PRVC, PRVC + PSV, APRV + PSV), resuscitation mode (CPR, RSA, HFNC), etc.; and has functions such as ETCO2, ring chart, respiratory mechanics and trend chart. The T7 ventilator can display pressure waveform, flow waveform, tidal volume waveform, ETCO2 waveform and interface parameters (pressure, tidal volume, ETCO2, FIO2) in real time. The T5 ventilator is intended for use in out-of-hospital emergency treatment (first aid treatment on the ground, at sea, and in the air) and in-hospital transportation run under the central oxygen supply of the hospital or an oxygen cylinder pressure greater than 2.7Bar.

04/08/2020 Philips Respironics E30 ventilator Ventilator, Continuous, Minimal Ventilatory Support, Facility Use The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs. It is intended to be used in the hospital or other institutional healthcare environments, as well as spaces converted for the care of large numbers of COVID-19 patients (e.g. convention centers, university dormitories, motels). The Philips Respironics E30 ventilator is intended for use by qualified, trained personnel under the direction of a physician.
04/08/2020 Incoba LLC Apogee Oxygen Conserver

The Apogee gas conserver is intended as a delivery device for medical grade oxygen from high-pressure oxygen cylinders. This is an ambulatory device which allows patients to ambulate longer than they would with a continuous flow regulator on the same cylinder. The Apogee is intended to be used in the hospital, healthcare facilities, or home care environments.

The Apogee Device shall be used by trained professionals either in a doctor's office or clinical setting initially. However, once recommended by the physician or healthcare provider the device can be prescribed for use within a home environment for subsequent treatments.

The Apogee Device essential performance is to provide short puffs of air during operation as noted on the display for nasal output L or R. In the event air is not delivered use the bypass adaptor and return the device to Dynaris for immediate replacement.

The Apogee unit is a regulated device and carries warnings and cautions regarding safe use of this product. Failure to read this manual and adhere to the warnings and caution stated within the manual can affect device performance and potentially harm to the user.

The Apogee Device and its accessories do not contain any natural rubber latex-containing components.

04/13/2020 SecondBreath LLC Pneumatic Resuscitator device Emergency Resuscitator The SecondBreath LLC Pneumatic Resuscitator is an electric pneumatic ventilator. This system uses compressed air to drive a pneumatic cylinder equipped with a plunger to compress an AMBU bag and provides the patient with positive inspiratory pressure. This device is intended only for use for transport or emergency resuscitation unless there are no other ventilation modalities available due to emergency resource limitations. The user can set tidal volume (TV), inspiratory to expiratory (I:E) ratio, respiratory rate, expiratory pause, and inspired oxygen (FiO2) at a constant 1.0 rate. Pure oxygen can be delivered through the AMBU bag. The device can only be operated in volume control (VC) continuous mandatory ventilation mode. Continuous end-tidal carbon dioxide monitoring is required for safe use of this device since there are no alarms for TV not met/exceeded. Additionally, power supply needs to be monitored as there is a loss of power alarm but no backup power supply to provide ventilation.
04/14/2020 University of Minnesota Medical School and Boston Scientific Corporation Coventor Adult Manual Resuscitator Compressor Emergency Resuscitator This device is intended for compression of an adult manual resuscitator device intended for pulmonary resuscitation of adult patients for whom no other appropriate means of mechanical ventilation exists due to resource limitations from pandemic conditions in the region of use.
04/14/2020 Umbulizer UMV-001 EUA Emergency Resuscitator The Umbulizer UMV-001 is intended to provide ventilatory support to adults when Positive Pressure Ventilation (PPV) is required to manage Acute Respiratory Failure (ARF). The Umbulizer series is appropriate for adults that weigh at least 45 kg (approximately 99 lbs). It is intended to be used in a pre-hospital, field hospital, and transport environments, as well as hospital settings where sufficient standard ventilators are not available.
04/16/2020 Hillrom MetaNeb 4 Intermittent Positive Pressure Breathing Device The MetaNeb 4 System is indicated for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen. Patient Population â€" 5 years old and above whom can follow verbal instructions. Environment of Use â€" Hospitals, sub-acute and nursing facilities, physician offices, clinics, and home settings.
04/17/2020 Spiro Devices LLC Spiro Wave (Amended June 8, 2020) Emergency Resuscitator The Spiro Wave is an automated manual resuscitator that has been designed specifically to meet AAMI guidelines for emergency use resuscitators and provide respiratory support for adult patients in acute respiratory failure. It does not replace standard mechanical ventilation but acts as a bridge to standard mechanical ventilation by increasing the functionality of existing manual resuscitator bags. The Spiro Wave is compatible with existing manual resuscitator bags, and clinicians can control key ventilatory parameters. The Spiro Wave is designed to provide basic ventilator functionality to a single adult patient, in an emergency situation when there are no other options available to the patient.
04/17/2020 RESMED AirCurve 10 ST-A Ventilator, Continuous, Minimal Ventilatory Support, Facility Use The AirCurve 10 ST-A is indicated to provide noninvasive ventilation for patients weighing more than 30lbs (13 kg) with respiratory insufficiency or obstructive sleep apnea (OSA). The iVAPS mode is indicated for patients weighing more than 66lbs (30 kg). The AirCurve 10 ST-A is intended for home and hospital use. The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment.
04/17/2020 PVA PREVENT Emergency Resuscitator PREVENT is indicated for emergency resuscitation with appropriate critical care monitoring on adult patients weighing at least 66 pounds that require mechanical respiratory support where standard ventilators are not available during the National Emergency.
04/20/2020 3B Medical Inc Luna G3 B30VT Ventilator, Continuous, Minimal Ventilatory Support The G3 B30VT BPAP is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide non-invasive ventilation for patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. These devices are intended for adult patients by prescription in the home or hospital/institutional environment.
04/20/2020 Resvent iBreeze PAP Ventilator, Continuous, Minimal Ventilatory Support, Facility Use The iBreeze PAP system delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea (OSA) in spontaneously breathing patients weighting over 30kg (66lbs) for use in the home, hospital, or institutional environment.
04/22/2020 Virgin Orbit Virgin Orbit Resuscitator (Amended
April 23, 2020)
Emergency Resuscitator This emergency use resuscitator is for use with appropriate critical care monitoring on adults (>18 years of age) requiring mechanical ventilation during declaration of National Emergency where ventilator need has surpassed ventilator supply and no other ventilatory support devices are available.
04/23/2020 Amsino International Inc's YUWELL YH-725 BiPAP Ventilator, Non-Continuous The YH-725 Bi-level device is indicated for treatment of sleep apnea hypopnea syndrome in patients weighing more than 66lb (30kg). It is intended both for home use and hospital use. The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment.
04/24/2020 AutoMedX Inc. SAVe II Series Ventilator Powered Emergency Ventilator The SAVe II series are intended to provide ventilatory support for adults during CPR or when Positive-Pressure Ventilation (PPV) is required to manage Acute Respiratory Failure (ARF) or other situations where mechanical ventilation is needed. The SAVe II series are appropriate for adults that weigh at least 45 kg. It is intended to be used in pre-hospital, field hospitals, outpatient environments, hospitals, ICU's, transport environments or any other healthcare environment requiring the use of ventilator.
04/24/2020 SLS Medical Technology Corp. Ltd. CP101/CP101S Series Ventilator, Non-Continuous This CPAP (Continuous Positive Airway Pressure) product can provide a continuous and positive airway in patients with respiratory insufficiency. This product provides 4~20 cmH2O of positive airway pressure and is equipped Oxygen Inlet to allow multiple Oxygen sources i.e. Oxygen generator. It is intended to be used under prescription of a physician.
04/24/2020 Zhejiang LifeMed Technology Co., Ltd. LA Series Ventilators LA20C, LA20A, LA20B, LA20B, LA25B, LA25B Ventilator, Non-Continuous The LifeMed LA Series Ventilator is a ventilator indicated for the treatment of respiratory insufficiency in patients weighing more than 30kg (66 lbs). It is intended for hospital use. The built-in humidifier is intended for repeated use by the same patient.
04/27/2020 Resvent Medical Technology CO., Ltd's iBreeze 30STA device Ventilator, Non-Continuous The iBreeze 30STA PAP system delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea (OSA) in spontaneously breathing patients weighing over 30kg (66lbs), it is for use in the home, hospital, or institutional environment.
04/28/2020 Shenzhen Yamind Medical Tech CPAP Devices: DM28-20C-G;
Auto CPAP Devices: DM28-20A-W, DM28-20A-WP;
BiPAP Devices: DM28-20S-G, DM28-20SA-G, DM28-20ST-G, DM28-25S-B, DM28- 25SA-BP, DM28-25ST-BP, DM28-30ST-B, DM28-30ST-BP, DM28-30STA-BP
Ventilator, Non-Continuous The subject device provides noninvasive ventilation for patients with obstructive sleep apnea. It is indicated for adult patients weighing more than 30kg and can be used in homes and hospitals. It is not intended for life support, or for central sleep apnea. It may be used to improve the oxygenation and ventilation in the treatment of acute respiratory illness or difficulty breathing.
04/30/2020 NASA Jet Propulsion Laboratory VITAL ventilator Emergency Ventilator The VITAL ventilator is intended to provide continuous ventilatory support for adult (body weight ≥ 50 kg) patients who require mechanical ventilation. VITAL provides patients with emergency
ventilatory support when no alternative standard ventilators are available. The VITAL ventilator
is a restricted medical device intended for use by qualified healthcare provider who understands
the functionality of the device operating under the direction of a physician.
04/30/2020 Venti-Now Venti-Now Resuscitator
Model JM-P2020A
Emergency Resuscitator The Venti-Now resuscitator is indicated for continuous or intermediate mechanical support of adult patients who require mechanical ventilation. The resuscitator is a restricted medical device intended for use by qualified, trained personnel under the direction of a Physician for COVID-19/Emergency use when no FDA-cleared ventilators are available. It is essential to read, understand, and follow these instructions before using the Venti-Now resuscitator. The Venti-Now resuscitator is a volumetric device that compresses a disposable BVM bag to create the positive pressure airflow to the patient. As such its use is applicable for use where a BVM unit is in use today. In addition, the unit has means to control Tidal volume, Inhalation/Exhalation rates, and bpm that make it suitable for a broader range of target patients than manually pumped BVM bags.
05/01/2020 Wilcox Industries Corp Wilcox PATRIOT SAVR Emergency Ventilator

PATRIOT SAVR is indicated for emergency continuous or intermittent mechanical support of adult patients when their ventilatory status cannot be maintained by high flow oxygen by nasal cannula, and a FDA cleared ventilator is not available.

Target Patients

The SAVR is applicable for adult patients who require the general types of invasive or non-invasive ventilatory support, as prescribed by an attending doctor:

  • Positive Pressure ventilation
  • Assist/Control, SIMV modes of ventilation The SAVR provides multiple alarms states but minimal monitoring capability, and thus the level of patient criticality should be considered before use. It is not indicated for Level 3 Critical Care patients. Target Environments

The ventilator is suitable for use in institutional and portable settings.

Target Operators

This ventilator must be used only under the responsibility and on the prescription of a doctor. The ventilator may be operated by the following caregivers:

  • Respiratory therapists
  • Doctors
  • Nurses
05/01/2020 Elemaster S.p.A. Tecnologie Elettroniche Mechanical Ventilator Milano (MVM) Emergency Ventilator

The MVM is a pressure-regulated mechanical ventilator designed for adult patients to provide emergency ventilatory support when no alternative standard ventilators are available.

The device should be used by:

  • healthcare professionals responsible for the treatment of a patient on ventilation support equipment, and
  • staff who will be performing routine maintenance on the device. The MVM is intended to provide ventilation support for intensive therapy during the COVID-19 pandemic for patients who require mechanical ventilation and weigh more than 40 kg (88 lbs).
05/02/2020 BMC Medical CO., LTD., China Luna G3 BPAP S/T- LG3800-G3 B30VT Ventilator, Continuous, Minimal Ventilatory Support The G3 B30VT BPAP is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide non-invasive ventilation for patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. These devices are intended for adult patients by prescription in the home or hospital/institutional environment.
05/02/2020 ZIBO ZHONGXUN MEDICAL EQUIPMENT CO. LTD ZXH-550 Emergency Ventilator The ventilator is intended to provide continuous ventilatory support for adult patients who require mechanical ventilation. The ventilator is a restricted medical device intended for use in hospitals and hospital-type facilities, which provide respiratory care for patients requiring respiratory support.
05/02/2020 JIUXIN MEDICAL JIXI H-100 Emergency Ventilator The ventilator is intended to provide continuous ventilatory support for adult patients who require mechanical ventilation. The ventilator is a restricted medical device intended for use in hospitals and hospital-type facilities, which provide respiratory care for patients requiring respiratory support.
05/05/2020 Vayu Global Health Innovations Vayu bubble Continuous Positive Airway Pressure Circuit ("Vayu bCPAP') Continuous Positive Airway Pressure Circuit The Vayu bCPAP system is intended to provide continuous positive airway pressure in the hospital environment to spontaneously breathing neonates and infants, up to 5 kg in weight, that require respiratory support due to conditions associated with prematurity, such as Respiratory Distress Syndrome, or other conditions where the physician desires and prescribes CPAP.
05/06/2020 Hunan Beyond Medical Technology Co., Ltd BEYOND C20A CPAP Ventilator, Continuous, Minimal Ventilatory Support The C20A CPAP is designed for delivery of positive airway pressure to provide non-invasive ventilation for adult patients with respiratory insufficiency or obstructive sleep apnea (OSA) in home or hospital environment.
05/06/2020 Hunan Beyond Medical Technology Co., Ltd BEYOND B30P BiPAP Ventilator, Continuous, Minimal Ventilatory Support The B-30P BiPAP is designed for delivery of positive airway pressure to provide non-invasive ventilation for adult patients with respiratory insufficiency or obstructive sleep apnea (OSA) in home or hospital environment. The device is to be used only under the prescription of a licensed health care professional.
05/06/2020 Guangzhou Hypnus Healthcare Co., Ltd. Hypnus ST730 Ventilator, Continuous, Minimal Ventilatory Support The device is indicated to provide non-invasive positive airway pressure to spontaneously breathing patients weighing over 30kg with Obstructive Sleep Apnea (OSA) or respiratory insufficiency. This device is intended for hospital and home use. It is not intended for patients dependent on mechanical ventilation.
05/07/2020 AutoMedX, Inc. SAVe II+ (M50016, M50017) Powered Emergency Ventilator The SAVe II series are intended to provide ventilatory support for adults during CPR or when Positive-Pressure Ventilation (PPV) is required to manage Acute Respiratory Failure (ARF) or other situations where mechanical ventilation is needed. The SAVe II series are appropriate for adults that weigh at least 45 kg. It is intended to be used in pre-hospital, field hospitals, outpatient environments, hospitals, ICU's, transport environments or any other healthcare environment requiring the use of a ventilator.
05/08/2020 Taiyuan Shanghai Medical Fabius Plus / Fabius Plus XL Gas Machine, Anesthesia Fabius plus is an inhalation anesthesia workstationfor use in operating, induction and recovery rooms.It may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders.Fabius plus is equipped with a compact breathing system, providing fresh-gas decoupling, PEEP, and pressure limitation. The following ventilation options are available: –Volume Controlled Ventilation -Pressure Controlled Ventilation (Optional) –Pressure Support (Optional) –SIMV/PS (Optional) –Manual Ventilation –Spontaneous Breathing. Fabius plus is equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratoryoxygen concentration (Fi02).
05/08/2020 Somnetics International, Inc. Transcend 3 BiPAP Ventilator, Non-Continuous The Transcend 3 BiPAP is intended for the therapy of adults weighing over 66 pounds (30 kg) with mild to moderate respiratory distress. The device delivers positive airway pressure (PAP), specifically positive end-expiratory pressure (PEEP) with ventilatory support, to provide ventilation assistance and breathing support. The device is intended for use in healthcare settings.
05/12/2020 Lanick Med Systems LLC Lyra x1 and Lyra x2 Ventilators Ventilator, Continuous, Facility Use

The LYRA xl ventilator is a mechanical ventilator designed to provide invasive and noninvasive, continuous or intermittent. respiratory support for pediatric and adult patients.

Intended areas of use:

  • In the intensive care ward or in the recovery room.
  • During transfer of-ventilated patients within the hospital. The LYRA xl ventilator is intended for use by qualified. trained personnel under the direction of a physician and within the limits of its stated technical specifications.

The LYRA x2 ventilator is a mechanical ventilator designed to provide invasive and noninvasive, continuous or intermittent, respiratory support for pediatric and adult patients. Intended areas of use:

  • In the intensive care ward or in the recove1y room 
  • During transfer of ventilated patients within the hospital. The LYRA x2 ventilator is intended for use by qualified, trained personnel under the direction of a of a physician and within the limits of its stated technical specifications. May 12,
05/15/2020 CMI Health Beijing Aeonmed Shangrila510S Emergency Transport Ventilator The Shangrila510S is an emergency transport ventilator intended to be used to provide ventilatory support in the emergency rooms of hospitals, transfer after operations, field and occasions where first aid or transfer is needed for care of adult ,pediatric patients weighting at least 3.5 kg who require mechanical ventilation.
05/18/2020 SysMed (China) Co., Ltd VM series- DPAP20 Plus, DPAP25 Plus, DPAP25 Pro, DPAP30 Pro Ventilator, Continuous, Minimal Ventilatory Support The device delivers positive pressure therapy for the treatment of Obstructive Sleep Apnea or respiratory insufficiency in spontaneously breathing adults weighing over 30kg (66 lbs). It is for use in the home or hospital/institutional environment.
05/20/2020 SysMed (China) Co., Ltd Resware BI 20 S, Resware BI Auto S, Resware BI 25 S/T, Resware BI 30 S/T, ZiZ Auto, Aurora Bi-Level S, Aurora Bi-Level S/T, Aurora Bi-Level Auto S Ventilator, Continuous, Minimal Ventilatory Support The Resware, ZiZmer, and Aurora CPAP products provide positive pressure therapy for the treatment of obstructive sleep apnea or respiratory insufficiency in spontaneously breathing adults weighing over 30 kg (66 lbs). This product can be used in the home as well as in clinical/hospital environments.
05/22/2020 Guangzhou Hypnus Healthcare Co., Ltd BA825W, BA825, ST830W and ST830 Ventilator, Continuous, Minimal Ventilatory Support Hypnus Positive Airway Pressure Device 8 Series are indicated to provide non-invasive positive airway pressure to spontaneously breathing patients weighing over 30kg with Obstructive Sleep Apnea (OSA), and BPAP-T mode and BPAP-ST mode can be used for respiratory insufficiency. This device is intended for hospital and home use. It is not intended for patients dependent on mechanical ventilation.
05/22/2020 Origin Medical Devices Inc. Panther 5 Model P5DLVENT Ventilator, Continuous, Facility Use The PANTHER 5 ventilator is intended to provide continuous ventilation to adult patients requiring respiratory support. The device is intended for facility use under clinical supervision.
06/01/2020 NASA Jet Propulsion Laboratory VITAL Compressor Emergency Ventilator The VITAL Compressor ventilator is intended to provide continuous ventilatory support for adult (body weight ≥ 50 kg) patients who require mechanical ventilation. VITAL provides patients with emergency ventilatory support when no alternative standard ventilators are available. The VITAL Compressor ventilator is a restricted medical device intended for use by qualified healthcare provider who understands the functionality of the device operating under the direction of a physician.
06/01/2020 Fitbit Fitbit Flow Emergency Resuscitator The Fitbit Flow is indicated for the continuous mechanical ventilatory support of adult patients. The Fitbit Flow is an accessory to a manual resuscitator and consists of a reusable mechanical actuator and the single-use, disposable tubing assembly. The Fitbit Flow supports conventional Volume Control and Pressure Control modes of ventilation, as well as an "Assist Control" feature to support breaths triggered by the patient. The Fitbit Flow is intended for use by qualified, trained personnel under the direction of a physician only when an FDA-cleared clinical ventilator is not available during the COVID-19 pandemic.
06/08/2020 BioMedInnovations, LLC SuppleVent Emergency Ventilator The SuppleVent Ventilator is an Emergency Use Ventilator (EUV) indicated to provide continuous ventilatory support of adult patients who require mechanical ventilation when an FDA cleared ventilator is not available due to COVID-19 pandemic. The ventilator is intended for institutional use by qualified, trained personnel under the direction of a doctor. Institutional use includes Intensive Care Unit (ICU) or other hospital environments including intra-hospital transport and temporary hospital facilities.
06/09/2020 Nanotronics Imaging, Inc nHale BiPAP device Ventilator, Continuous, Minimal Ventilatory Support The nHaleTM is a bi-level positive air pressure (BIPAP) device to support respiratory therapy of spontaneously breathing adults weighing over 30kg suffering from COVID-19 disease in traditional healthcare facilities (e.g., hospitals, assisted living facilities, nursing homes) as well as spaces converted for the care of large numbers of COVID-19 patients (e.g., convention centers, university dormitories, motels, etc.). The nHaleTM is a non-invasive ventilator designed to be used in non-life-threatening situations, for spontaneously breathing patients, where a patient is in need of breathing assistance but is not in need of invasive ventilatory support based on standard medical protocols.
06/10/2020 Enexor BioEnergy, LLC X-VENT Emergency Ventilator Emergency Ventilator

The X-VENT is a continuous use, emergency ventilator intended to provide invasive and non-invasive ventilatory support for adult patients > 35 kg of weight with respiratory insufficiency or failure. The X-VENT is to be used under prescription only and is intended to be used in hospitals, hospital-type facilities, or other institutional health care environments. X-VENT provides patients with emergency ventilatory support when no alternative standard ventilators are available.

The X-VENT is intended for use by qualified physicians and respiratory therapists who have undergone training on the use of the X-VENT ventilator. It provides three (3) modes of ventilation: pressure control, volume control, and assist control (volume and pressure).

06/17/2020 NeoNatal Rescue, LLC AdultLife Pro Ventilator Emergency Ventilator The AdultLife Pro Ventilator is intended for emergency ventilatory care of hospitalized adult patients greater than 35kg in weight who are experiencing respiratory insufficiency or respiratory failure. The unit is designed to be used at the bedside in hospital environments, from an intensive care unit to other facilities, for use by trained professionals in respiratory care. Patients can be treated with the AdultLife Pro Ventilator for as long as their symptoms persist.  AdultLife Pro Ventilator provides patients with emergency ventilatory support when no alternative standard ventilators are available.
06/19/2020 World Ventilator Foundation (WVF) WorldVent Ventilator Emergency Ventilator

The World Ventilator Foundation (WVF) WorldVent is intended to provide continuous ventilation for adult patients who require invasive respiratory support. It provides Volume Controlled Ventilation (VCV) mode provided in both mandatory and spontaneous assist control fashions as well as respiratory monitoring.

The WorldVent is intended for use in hospitals and hospital-type facilities by properly trained healthcare professionals for short term ventilation in the adult population when no FDA cleared ventilators are available during the COVID-19 pandemic.

06/24/2020 Air Boost AustinP51 Emergency Resuscitator The AustinP51 is a portable emergency use resuscitator designed to provide either continuous or intermittent ventilatory support for patients requiring mechanical ventilation through volume control. The AustinP51 should only be used by those professionals who are qualified and trained in the use of general ventilation equipment, or who are specifically trained on the AustinP51 system. The AustinP51 emergency use resuscitator (EURS) is intended to treat adults during the COVID-19 pandemic as authorized by the appropriate FDA EUA and should only be used when no FDA cleared or approved ventilators are available.
06/26/2020 Stewart & Stevenson Healthcare Technologies, LLC Apollo ABVM Emergency Resuscitator The Apollo ABVM is an emergency use resuscitator intended for short term use under the direction of critical care physicians and respiratory therapists to provide continuous or intermittent mechanical ventilation to a patient only when an FDA-cleared clinical ventilator is not available during the COVID-19 pandemic. This device mechanically actuates a manual resuscitator and may assist patients in breathing support in order to meet emergency demands for ventilators. The Apollo ABVM is intended for application for adult patients only. The Apollo ABVM is restricted medical device intended for use in hospitals only
06/26/2020 SAGICO USA, LLC V2O SAGICO SYSTEM Ventilator, Continuous, Facility Use

The V2O SAGICO SYSTEM Ventilator is an electronically controlled, electronically powered machine, which is used in ICU, in Respiratory Department or Emergency Department for the rescue and therapy of the patient with respiratory insufficiency, and in other departments for providing respiratory support for the patient.  The V2O SAGICO SYSTEM is to be used only by properly trained healthcare professionals.

Authorized Ventilator Tubing Connectors

Date of Authorization Manufacturer Product Name Device Description Intended Use
03/25/2020 Prisma Health Ventilation Expansion Splitter (VESper) VESper allows multiple patients to be treated by a single ventilator A single ventilator fitted with the Vent Splitter can be used for multiple patients for ventilatory support during the COVID-19 pandemic when individual ventilators are not available or preemptively to increase the potential of single-use ventilators permitting mechanical ventilation for multiple patients simultaneously
04/15/2020 Vent Multiplexor LLC Vent Multiplexor Dual Patient Circuit Connector The Vent Multiplexor is intended to provide temporary rescue mechanical ventilation for dual patient ventilation until an additional ventilator is available to resume single mechanical ventilation or as soon as respiratory recovery is attained in either patient.
04/19/2020 MakeMedical VentMI Dual Patient Circuit Connector A single ventilator fitted with the VentMI Ventilator Splitter can be used for two adult patients with the same pathology for ventilatory support for up to fourteen (14) days during the COVID-19 pandemic when individual ventilators are not available.
04/29/2020 Northwell Health, Inc. Northwell 3D Printed BiPAP Adapter Ventilator Tubing Connector The Northwell Health 3D Printed BiPAP Adapter ("Adapter") is intended for use as an exhalation port that enables invasive use of a bilevel positive airway pressure (BiPAP) machine with a pressure control ventilation (PCV) option as a pressure-controlled ventilator.
04/29/2020 Formlabs Inc. Formlabs 3D Printed BiPAP Adapter Ventilator Tubing Connector The Formlabs 3D Printed BiPAP Adapter ("Adapter") is intended for use as an exhalation port that enables invasive use of a BiPAP with a pressure control ventilation (PCV) option as a pressure-controlled ventilator.
05/05/2020 Covidien LLC DAR Adult Dual Patient Breathing Circuit 301P14429 Dual Patient Circuit Connector The Adult Dual Breathing Circuit can be used for two patients for ventilatory support during the COVID-19 pandemic when individual ventilators are not available to increase the potential of single-use ventilators permitting mechanical ventilation for two patients simultaneously.
05/07/2020 Safe Flight Instrument Corporation Safe Flight 9100-3 Quad Vent Patient Circuit Connector The intended use of the Safe Flight 9100-3 Quad/Vent ventilator splitter is to enable a single ventilator to be shared between multiple patients for ventilator support. Is intended to provide temporary rescue mechanical ventilation for multi-patient ventilation only when single mechanical ventilation is not possible due to shortage.
05/07/2020 Safe Flight InstrumentCorporation Safe Flight 9100-1 Quad Vent Patient Circuit Connector The intended use of the Safe Flight 9100-1 Quad/Vent ventilator splitter is to enable a single ventilator to be shared between multiple patients for ventilatory support. Is intended to provide temporary rescue mechanical ventilation for multi-patient ventilation only when single mechanical ventilation is not possible due to shortage.
05/08/2020 Stryker Instruments Flow Control Valve Patient Circuit Connector The Flow Control Valve is intended for use on patients suffering from acute respiratory failure. During the COVID-19 pandemic, when the number of patients requiring ventilation exceeds the number of ventilators, the Flow Control Valve enables a single ventilator to be used to provide ventilator support to two patients. The Flow Control Valve is used to regulate the flow once the breathing circuit has already been split by a T-piece. This device is only intended to be used in the setting of an acute shortage of ventilators, as a lifesaving measure to provide acute ventilatory support in times of scarcity when other standard single ventilators are not available. The Flow Control Valve is only suitable for use with ventilators that have separate inspiratory expiratory ports, such as Critical Care Ventilators and Anesthesia machines.
05/13/2020 Valhalla Medical Supply, LLC Single-Use Emergency Ventilator 2-Way Manifold Dual Patient Circuit Connector The Single-Use Emergency Ventilator 2-Way Manifold (vent splitter) is intended to allow a single ventilator to be used simultaneously to provide ventilatory support of two adult patients with similar lung compliances and respiratory needs during the COVID-19 pandemic when individual ventilators are not available.
05/29/2020 Bloom Energy Ventilator Sharing and Monitoring Patient Circuit Connector The Ventilator Sharing and Monitoring System allows a single critical care ventilator to be used for up to four adult patients for ventilator support during the COVID-19 pandemic when individual ventilators are not available.
06/16/2020 The New Bureau The Single Path Airway Rapid Retrofit Optional Workflow ("Sparrow") COVID-19 Co-Ventilator Assist Device Dual Patient Circuit Connector The Sparrow COVID-19 Co-Ventilator Assist Device is a ventilator circuit splitter used to adapt a single mechanical ventilator for use by more than one patient when individual ventilators are not available.  It is not intended to be used when the supply of available ventilators is sufficient to provide individual mechanical ventilation.

Authorized Ventilator Accessories

Date of Authorization Manufacturer Product Name Device Description Intended Use
04/13/2020 SMD Manufacturing, LLC ReddyPort Mini NIV Access Elbow Elbow Connector for Mask The ReddyPort Mini NIV Access Elbow is intended to provide an interface for application of CPAP or bi-level therapy. The elbow is for single patient use in the hospital/institutional environment. The elbow is to be used on patients 7 years or older (>40lbs/18.2kg) for whom CPAP or bi-level therapy has been prescribed
04/14/2020 3B Medical, Inc. 3B Hi-Flow H80 Respiratory Humidifier H-80 series humidifier is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases. This device is for patients by prescription in the home or hospital/institutional environment. The device is only allowed to be used after the physician provides guidance for the patient and targeted setting of the device; the physician should ensure that the patient understands all functions and methods of operation of the device.
04/28/2020 Janisys Janisys CPAP Flow Generator Positive End Expiratory Pressure Breathing Attachment The Janisys CPAP Flow Generator, when used in conjunction with a PEEP valve, is used to provide CPAP to a spontaneously breathing adult in hospital settings. The DD-3 variable-flow model is intended to provide 28%-100% FIO2 and the DD-4 fixed-flow model is intended to provide 28%-33% FIO2.
05/20/2020 Vincent Medical Manufacturing Co., Ltd O2FLO High Flow Respiratory Humidifier (VUN-001) Respiratory Humidifier The O2FLO High Flow Heated Respiratory Humidifier (VUN-001) is intended to deliver warmed and humidified respiratory gases to spontaneously breathing patients with a flow rate from 2LPM to 60LPM and is capable of providing high flow therapy. The device can be used in the emergency room, outpatient department, inpatient department and other diagnostic and treatment rooms.
06/23/2020 Vincent Medical (Dong Guan) Manufacturing. Co., LTD. Heat and Moisture Exchanging Filters (HMEF): HMEF 1000 Straight (Model 504-011, part number 51008027), HMEF 1000 Angled (Model 504-011, part number 51008028), HMEF Midi Straight (Model 504-011, part number 51008029), HMEF Midi Angled (Model 504-011, part number 51008030); and Bacterial / Viral Respirator Filters: BSF103 low resistance (Model 510-014, part number 51008082) and BSF201 High performance (Model 504-011, part number 51008083) Breathing Circuit Filters

HME / Filter - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired and to maintain moisture levels in the patient’s respiratory tract during anesthesia, artificial respiration, and other types of assisted ventilation. Use up to 24 hours. For adults with Tidal Volumes > 300 ml.

Filter only - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired. Use up to 24 hours. For adults with tidal volume > 300 ml.

07/08/2020 Circadiance SleepWeaver Prevent Mask Ventilator, non-continuous, Mask The SleepWeaver Prevent Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or Bi-Level therapy. This mask is intended for single-patient reuse in the home and single-patient reuse in the hospital / institutional environment. This mask is to be used on patients greater than 66 lbs (30 kg). The filter mask present in SleepWeaver Prevent is intended to filter exhaled air to reduce the likelihood that the exhaled air may contaminate the room air around the person using the mask.
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