DEVICE: B Medical Systems (00545010453397)

Device Identifier (DI) Information

B Medical Systems
BR490G
In Commercial Distribution
991.6647.56
B Medical Systems SARL
00545010453397
GS1

1
377142935 *Terms of Use
Blood storage refrigerator
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
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 bank refrigerator A mains electricity (AC-powered) appliance specially designed to store whole blood and blood components (e.g., blood cells or plasma) at temperatures ranging from 1° to 6° Celsius in a blood bank. The device includes an integrated alarm that warns against unexpected temperature increases.
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FDA Product Code

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Product Code Product Code Name
KSE Refrigerator, Freezer, Blood Storage
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FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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

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Size Type Text
No Device Sizes
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Device Record Status

b0475351-e514-49e7-99ea-3f281ea540fa
March 29, 2018
2
December 22, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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