AccessGUDID - DEVICE: Glycerolyte 57 Solution (04086000101288)

GUDID

Device Identifier (DI) Information

Brand Name: Glycerolyte 57 Solution
Version or Model: 4A7833
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4A7833
Company Name: Fresenius Kabi AG

Primary DI Number: 04086000101288
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315654579 *Terms of Use

Device Description: 500 ML. Cryopreservative processing solution for manufacture of Red Blood Cells, Frozen. Not for intravenous infusion.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46813	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSW	System, Processing For Frozen Blood

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK180254	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8569838a-e855-4abd-af35-507cdf071afb
Public Version Date: June 26, 2023
Public Version Number: 3
DI Record Publish Date: September 02, 2016