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Siemens Industry, Inc. SITRANS F M 1100F Magnetic Flow Meter, Model Numbers 7ME6140-2Rxxx-xxxx (1 ½”), 7ME6140-2Yxxx-xxxx (2”), 7ME6140-3Fxxx-xxxx (2 ½”), 7ME6140-3Mxxx-xxxx (3”), and 7ME6140-3Txxx-xxxx (4”) with MAG5000 Transmitter, Model Number 7ME6910-xxxxx-xxxx

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HHS:PHS:FDA:CFSAN:OFS:DPDFS:DEB:MST

5100 Paint Branch Parkway
College Park, MD 20740-3835

M-b-371

October 23, 2013

TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists

FROM: Dairy and Egg Branch/Milk Safety Team (HFS-316)

SUBJECT: Siemens Industry, Inc. SITRANS F M 1100F Magnetic Flow Meter, Model Numbers 7ME6140-2Rxxx-xxxx (1 ½”), 7ME6140-2Yxxx-xxxx (2”), 7ME6140-3Fxxx-xxxx (2 ½”), 7ME6140-3Mxxx-xxxx (3”), and 7ME6140-3Txxx-xxxx (4”) with MAG5000 Transmitter, Model Number 7ME6910-xxxxx-xxxx

In accordance with M-I-00-2, Milk and Milk Product Equipment - A Guideline for Evaluating Construction, FDA’s Pacific/Southwest Region Milk Specialists and CFSAN’s Dairy and Egg Branch/Milk Safety Team have specifically evaluated the Siemens Industry, Inc. SITRANS F M 1100F Magnetic Flow Meter, Model Numbers 7ME6140-2Rxxx-xxxx (1 ½”), 7ME6140-2Yxxx-xxxx (2”), 7ME6140-3Fxxx-xxxx (2 ½”), 7ME6140-3Mxxx-xxxx (3”), and 7ME6140-3Txxx-xxxx (4”) with MAG5000 Transmitter, Model Number 7ME6910-xxxxx-xxxx, and have validated and confirmed the technical information submitted by Siemens Industry, Inc. and the review findings of the Pacific/Southwest Region Dairy Equipment Review Committee (PSRDERC).

When the Siemens Industry, Inc. SITRANS F M 1100F Magnetic Flow Meter, Model Numbers 7ME6140-2Rxxx-xxxx (1 ½”), 7ME6140-2Yxxx-xxxx (2”), 7ME6140-3Fxxx-xxxx (2 ½”), 7ME6140-3Mxxx-xxxx (3”), and 7ME6140-3Txxx-xxxx (4”) with MAG5000 Transmitter, Model Number 7ME6910-xxxxx-xxxx is constructed, installed, operated and maintained in accordance with the submission handbook titled “UMSITRANSFM1100FDA 0313”, the above cited models have been determined to meet the applicable provisions of the Grade “A” Pasteurized Milk Ordinance (PMO).

The technical information that was submitted by Siemens Industry, Inc. and reviewed by PSRDERC addressing the Siemens Industry, Inc. SITRANS F M 1100F Magnetic Flow Meter, Model Numbers 7ME6140-2Rxxx-xxxx (1 ½”), 7ME6140-2Yxxx-xxxx (2”), 7ME6140-3Fxxx-xxxx (2 ½”), 7ME6140-3Mxxx-xxxx (3”), and 7ME6140-3Txxx-xxxx (4”) with Mag 5000 Transmitter, Model Number 7ME6910-xxxxx-xxxx constitutes PSRDERC's Engineering Design and Technical Construction File (EDTCF) PR-10-01. The material in the EDTCF is the property of Siemens Industry, Inc. and may be provided at their discretion. 

For additional information regarding this equipment and to request a copy of the documents listed, please contact:

Siemens Industry, Inc.
1201 Sumneytown Pike
Spring House, PA 19477
Attn: Denny Petrovich
Phone: (215) 206-4606
Email: dennis.petrovich@siemens.com

FDA’s review and acceptance of the Siemens Industry, Inc. SITRANS F M 1100F Magnetic Flow Meter, Model Numbers 7ME6140-2Rxxx-xxxx (1 ½”), 7ME6140-2Yxxx-xxxx (2”), 7ME6140-3Fxxx-xxxx (2 ½”), 7ME6140-3Mxxx-xxxx (3”), and 7ME6140-3Txxx-xxxx (4”) with MAG5000 Transmitter, Model Number 7ME6910-xxxxx-xxxx does not constitute FDA or Regulatory Agency endorsement or approval. Any representation on a label or in printed literature citing or indicating as “FDA Approved” would be considered as false and misleading.

An electronic version of this memorandum is available for distribution to Regional Milk Specialists, Milk Regulatory Agencies and Milk Sanitation Rating Officers in your region. The electronic version should be widely distributed to representatives of the dairy industry and other interested parties and will also be available on the FDA Web Site at http:www.fda.gov at a later date.

If you would like an electronic version of this document prior to it being available on the FDA Web Site, please e-mail your request to Robert.Hennes@fda.hhs.gov.

/s/

Randy Elsberry
FDA Regional Dairy Specialist
Pacific Region
  

/s/

Robert Hennes, RS, MPH
CAPT U.S. Public Health Service
Dairy and Egg Branch 

 

Attachment: UMSITRANSFM1100FDA 0313 - Table of Contents
Photo – Siemens Industry, Inc. SITRANS F M Magflo MAG5000 Transmitter

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Contents
PRDERC Dairy Equipment Submission Form………………………......1
SITRANS F M Magnetic Flow Meters …….………………...............….. ....2
SITRANS F M 1100F Sensor Series……….……………………….……...3
SITRANS F M MAG5000 Transmitter Series………………………….......4
1100F 3-A Certificate…………………………………………..….……........5
UMSITRANSFM1100FDA 0313……………..………………..…..…….......6
Sitrans F M Quick Start Guide……..…………………………….……….....7
Siemens Calibration Accreditation & Calibration Certificate…….…......8
Cheese HTST Test Results……………………..………………..………...9
Evaporator Test Results……………….…...…………………………...… 10
Whey Test Results…………………………………………...…..….……...11
MAG Transmitter Safeguards…………………………………...….…….. 12

 

Siemens Industry, Inc. SITRANS F M Magflo MAG5000 Transmitter

 Image of Siemens Industry, Inc. SITRANS F M Magflo MAG5000 Transmitter