DEVICE: B Medical Systems (00545010453228)
Device Identifier (DI) Information
B Medical Systems
FR750G
In Commercial Distribution
991.7037.51
B Medical Systems SARL
FR750G
In Commercial Distribution
991.7037.51
B Medical Systems SARL
Plasma storage freezer
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]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 -18° Celsius (-0.4° 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
[?]Product Code | Product Code Name |
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KSE | Refrigerator, Freezer, Blood Storage |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between -30 and 70 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d495d584-dcaa-4cd4-8824-9424687ac3e7
March 29, 2018
2
October 17, 2016
March 29, 2018
2
October 17, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined