DEVICE: Glycerolyte 57 Solution (04086000101288)

Device Identifier (DI) Information

Glycerolyte 57 Solution
4A7833
In Commercial Distribution
4A7833
Fresenius Kabi AG
04086000101288
GS1

1
315654579 *Terms of Use
500 ML. Cryopreservative processing solution for manufacture of Red Blood Cells, Frozen. Not for intravenous infusion.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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 storage solution, freezing A blood preservation fluid used during the collection and storage of blood and blood components in a healthcare and/or a blood bank facility (typically in a laboratory associated with the collection of blood or during apheresis procedures that result in the collection of blood), to help maintain protein and blood cell viability during the freezing of blood. It is typically glycerol-based and is supplied in a container (e.g., a polypropylene bag); it is not for direct intravenous infusion. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
KSW System, Processing For Frozen Blood
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FDA Premarket Submission

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

Sterilization

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

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Storage and Handling
Special Storage Condition, Specify: Prior to use, the temperature of the product should be brought to equilibrium with the working environment typically ranging from 20 to 25°C.
Special Storage Condition, Specify: Prior to use, the temperature of the product should be brought to equilibrium with the working environment typically ranging from 20 to 25°C.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

8569838a-e855-4abd-af35-507cdf071afb
March 29, 2018
2
September 02, 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
14086000101285 12 04086000101288 In Commercial Distribution Carton
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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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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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