Home GUDID 04086000101271 Glycerolyte 57 Solution
Primary DI 04086000101271
Brand Glycerolyte 57 Solution
Company Fresenius Kabi AG
Model 4A7831
Catalog number 4A7831
Device description 400 ML. Cryopreservative processing solution for manufacture of Red Blood Cells, Frozen. Not for intravenous infusion.
Published 2016-09-02
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name KSW System, Processing For Frozen Blood
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KSW System, Processing For Frozen Blood Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 14086000101278 Package GS1 12 In Commercial Distribution 04086000101271 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 14086000101278 14086000101278 04086000101271 04086000101271 4086000101271
GMDN Terms# Term, Definition table Term 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.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Prior to use, the temperature of the product should be brought to equilibrium with the working environment typically ranging from 20 to 25°C.
Regulatory Flags# DUNS number 315654579 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00811505030573 Ivenix SET-0040-1 SET-0040-1 2026-06-02 00811137013104 Amicus Separator 6R4590R 6R4590R 2026-03-11 00810020442229 Amicus MNC Apheresis Kit - Double Needle X7R2326SB X7R2326SB 2026-02-03 01081002044222 Amicus MNC Apheresis Kit - Double Needle X7R2326SB X7R2326SB 2026-02-03 04086000860888 COMPOGUARD Advance Basic 9029741 9029741 2024-10-30 04086000860895 COMPOGUARD Advance Data 9029751 9029751 2024-10-29 04086000860901 COMPOGUARD Advance COMPLETE 9029761 9029761 2024-10-29 04086000860741 CompoGuard Basic (NA) 9029641 9029641 2022-11-10 04086000860758 CompoGuard Data (NA) 9029651 9029651 2022-11-10 04086000860765 CompoGuard Complete (NA) 9029661 9029661 2022-11-10 04086000100199 ALYX 2RBC LR KIT X4R5720 X4R5720 2018-02-14 04086000100991 Fenwal AMICUS Apheresis Kit - Single Needle Functionally Closed 4R2367 4R2367 2016-09-09 04086000100984 Fenwal AMICUS Apheresis Kit - Double Needle Functionally Closed 4R2365 4R2365 2016-09-09 00810020440164 AMICUS Single Needle Advanced Kit with 20 mL Platelet Sampling System Assembly 4R2353G 4R2353G 2020-10-20 04086000101370 Fenwal AMICUS Single Needle Advanced Kit 4R2353 4R2353 2016-09-02 04086000101387 Fenwal AMICUS Double Needle Advanced Kit 4R2354 4R2354 2016-09-02 00810020440140 AMICUS Double Needle Advanced Kit with 20 mL Platelet Sampling System Assembly 4R2354G 4R2354G 2020-10-20 04086000101332 Fenwal AMICUS Apheresis Kit - Double Needle 4R2355 4R2355 2016-09-09 04086000101349 Fenwal AMICUS Apheresis Kit - Single Needle 4R2357 4R2357 2016-09-09 04086000100090 AMICUS Apheresis Kit – Single Needle X6R2312 X6R2312 2025-11-03
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