Device Product Codes (procodes) for Device Constituent Parts of ANDA/NDA/BLA Combination Products
The table below includes common procodes1 for device constituent parts of ANDA/NDA/BLA combination products:
| Device Constituent Part | Procode | Procode Description |
|---|---|---|
| Syringe | FMF | Syringe, Piston |
| Syringe with Injury Prevention Features | MEG | Syringe, Antistick |
| Autoinjector | KZH | Introducer, Syringe Needle |
| Needle-Free Injector, Jet Injector | KZE | Injector, Fluid, Non-Electrically Powered |
| Syringe Holder | IQG | Adaptor, Holder, Syringe |
| Ear, nose, and throat drug administration device | KCO | Nasal spray, ENT delivery |
| Nasal Spray for Systemic Delivery | QIY | Nasal spray, systemic delivery, CDER or CBER-led |
| Nebulizer | CAF | Nebulizer |
| IV Administration Sets/Kits | FPA | Set, Administration, Intravascular |
| IV Tubing | FPK | Tubing, Fluid Delivery |
| IV Bag | KPE | IV Container |
| Pressure Infusor for IV Bags | KZD | Infusor, Pressure for IV Bags |
| IV Transfer Set | LHI | Set, I.V. Fluid Transfer |
| Vial Adapter | ONB | Closed antineoplastic and hazardous drug reconstitution and transfer system |
| Medicine Cups | KYW | Container, Liquid Medication, Graduated |
| Oral Syringes, Droppers | KYX | Dispenser, Liquid Medication |
| Infusion Pumps | FRN | Pump, Infusion |
| Insulin Infusion Pumps | LZG | Pump, Infusion, Insulin |
| Infusion Pump Accessories | MRZ | Accessories, Pump, Infusion |
| Vaginal Applicators | HGD | Applicator, Vaginal |
| Disposable Manual Surgical Instruments (scalpels, clamps, etc.) | KDC | Instrument, disposable, surgical |
| Acupuncture Needle | MQX | Needle, Acupuncture, Single use |
| Transdermal Delivery System | QIX | System, transdermal delivery, CDER or CBER-led |
| Implantable Material for Controlled Release | QIZ | Material, implantable for controlled release, CDER or CBER-led |
| Metered Dose Inhaler and Dry Powder Inhaler | QKS | Inhaler, Metered Dose or Dry Powder, CDER or CBER-led |
| On-body injector | QLF | On-Body Injector |
| Intravaginal system for controlled release of drug substance | QLH | System, Intravaginal, for Controlled Release of Drug Substance, CDER or CBER-led |
| Vaporizer | QLI | Vaporizer, CDER or CBER-led |
| Pen Injector | NSC | injector, pen |
| Enteral Infusion Pump | LZH | pump, infusion, enteral |
| Hypodermic Needle | FMI | needle, hypodermic, single lumen |
| Infusion line filter | FPB | filter, infusion line |
| MDI and nebulizer spacer | NVO | spacer, direct patient interface |
| IUD introducer | HDT | device, intrauterine, contraceptive and introducer |
FDA maintains a searchable online procode database (that includes both procodes and device common names). A Combination Product Applicant may contact CDRH’s Division of Industry and Consumer Education (DICE) (DICE@fda.hhs.gov), as well as the Office of Combination Products (OCP) (combination@fda.gov), as needed, for assistance in determining the product code that most closely aligns with their device constituent part.
1 Please note, while this information is helpful for efficient review of ICSRs for all combination products with a device constituent part, selection of a procode for device constituent parts of ANDA/NDA/BLA combination products does not classify the device constituent part within that generic type of device or indicate whether the device constituent part would be classified within that generic type if submitted separately from the drug or biological product in an appropriate device application (see also Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff).