Identity
- Trade Name
- Human Serum Albumin FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- Human Albumin. Contains 100 mg/mL Human Serum Albumin. 100 ml FDA UDI
- Model / Reference
- ART-3003 FDA UDI
- Description
- Human Albumin. Contains 100 mg/mL Human Serum Albumin. 100 ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937818741 FDA UDI
- FDA Product Code
- MQL FDA UDI
- GMDN Term
- IVF medium FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6180 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: IVF medium
Human Serum Albumin by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- CooperSurgical, Inc.
Sources (1)
- FDA UDI d5ed0e89-5b0a-48b6-9a1b-49e0bcb6bb7e 34 fields · synced Jun 9, 2026