Identity
- Trade Name
- Glycerolyte 57 Solution FDA UDI
- Generic Name
- Blood storage solution, freezing FDA UDI
- Device Name
- 500 ML. Cryopreservative processing solution for manufacture of Red Blood Cells, Frozen. Not for intravenous infusion. FDA UDI
- Model / Reference
- 4A7833 FDA UDI
- Description
- 500 ML. Cryopreservative processing solution for manufacture of Red Blood Cells, Frozen. Not for intravenous infusion. FDA UDI
Identifiers
- Catalog Number
- 4A7833 FDA UDI
- Primary DI / UDI-DI
- 04086000101288 FDA UDI
- FDA Product Code
- KSW FDA UDI
- GMDN Term
- Blood storage solution, freezing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9145 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood storage solution, freezing
Glycerolyte 57 Solution by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood storage solution, freezing.
- Glycerolyte 57 Solution — Fresenius Kabi · Class II
Cleared under the same submission
BK180254 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fresenius Kabi
Sources (1)
- FDA UDI 8569838a-e855-4abd-af35-507cdf071afb 36 fields · synced May 30, 2026