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

Blood storage solution, freezing

• Primary Device ID: 04086000101288
• NIH Device Record Key: 8569838a-e855-4abd-af35-507cdf071afb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glycerolyte 57 Solution
• Version Model Number: 4A7833
• Catalog Number: 4A7833
• Company DUNS: 315654579
• Company Name: Fresenius Kabi AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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 Agency	Device ID
GS1	04086000101288 [Primary]
GS1	14086000101285 [Package]; Package: Carton [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK180254

FDA Product Code

• KSW: System, Processing For Frozen Blood

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-02

On-Brand Devices [Glycerolyte 57 Solution]

• 04086000101288: 500 ML. Cryopreservative processing solution for manufacture of Red Blood Cells, Frozen. Not for
• 04086000101271: 400 ML. Cryopreservative processing solution for manufacture of Red Blood Cells, Frozen. Not for