FDA UDI
In Commercial Distribution
🇺🇸 United States
Glycerolyte 57 Solution
DI: 04086000101271
·
Model: 4A7831
·
Fresenius Kabi AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Glycerolyte 57 Solution
- Primary DI
- 04086000101271
- Version / Model
- 4A7831
- Catalog Number
- 4A7831
- Company Name
- Fresenius Kabi AG
- Labeler DUNS
- 315654579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-02
- Public Version
- 3
- Public Version Date
- 2023-06-26
- Public Version Status
- Update
- Public Device Record Key
- 551870cc-e42b-45d3-94c6-2a81c7554121
Device Description
400 ML. Cryopreservative processing solution for manufacture of Red Blood Cells, Frozen. Not for intravenous infusion.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KSW | System, Processing For Frozen Blood | Hematology | 864.9145 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04086000101271 | GS1 | ||||
| Package | 14086000101278 | GS1 | Carton | 12 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK180254 | 0 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Prior to use, the temperature of the product should be brought to equilibrium with the working environment typically ranging from 20 to 25°C.