Glycerolyte 57 Solution 4A7833

GUDID 04086000101288

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

Fresenius Kabi AG

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Primary Device ID04086000101288
NIH Device Record Key8569838a-e855-4abd-af35-507cdf071afb
Commercial Distribution StatusIn Commercial Distribution
Brand NameGlycerolyte 57 Solution
Version Model Number4A7833
Catalog Number4A7833
Company DUNS315654579
Company NameFresenius Kabi AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.
Special Storage Condition, SpecifyBetween 0 and 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.

Device Identifiers

Device Issuing AgencyDevice ID
GS104086000101288 [Primary]
GS114086000101285 [Package]
Package: Carton [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSWSystem, Processing For Frozen Blood

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-02

On-Brand Devices [Glycerolyte 57 Solution]

04086000101288500 ML. Cryopreservative processing solution for manufacture of Red Blood Cells, Frozen. Not for
04086000101271400 ML. Cryopreservative processing solution for manufacture of Red Blood Cells, Frozen. Not for
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