AccessGUDID - DEVICE: B Medical Systems (00545010453228)

GUDID

Device Identifier (DI) Information

Brand Name: B Medical Systems
Version or Model: FR750G
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 991.7037.51
Company Name: B Medical Systems SARL

Primary DI Number: 00545010453228
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 377142935 *Terms of Use

Device Description: Plasma storage freezer

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Blood plasma freezer	A mains electricity (AC-powered) appliance designed to store blood plasma in a frozen state at temperatures at or below -18Ã‚Â° Celsius (-0.4Ã‚Â° Fahrenheit) for up to a year in a blood bank. The device typically includes internal shelving for storage and easy location of plasma containers (e.g., bags); a corrosion-resistant (typically stainless steel) interior to minimze the risk of adulteration, contamination, and/or corrosion of contents; forced-air circulation and automatic defrost capability; and sensors, controls, monitors, chart recorders (week-long recordings are typical), and alarms (over temperature, under temperature, and power failure).

GMDN Preferred Term Name

GMDN Definition

Blood plasma freezer

A mains electricity (AC-powered) appliance designed to store blood plasma in a frozen state at temperatures at or below -18Ã‚Â° Celsius (-0.4Ã‚Â° Fahrenheit) for up to a year in a blood bank. The device typically includes internal shelving for storage and easy location of plasma containers (e.g., bags); a corrosion-resistant (typically stainless steel) interior to minimze the risk of adulteration, contamination, and/or corrosion of contents; forced-air circulation and automatic defrost capability; and sensors, controls, monitors, chart recorders (week-long recordings are typical), and alarms (over temperature, under temperature, and power failure).

FDA Product Code

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Product Code	Product Code Name
KSE	Refrigerator, Freezer, Blood Storage

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Handling Environment Temperature: between -30 and 70 Degrees Celsius

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d495d584-dcaa-4cd4-8824-9424687ac3e7
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 17, 2016