Identity
- Trade Name
- 7% PVP Solution with HSA FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- Polyvinylpyrrolidone (PVP) dissolved in mHTF (an isotonic HEPES buffered medium) to make a 7% (w/v) solution. Contains 5 mg/mL Human Serum Albumin. FDA UDI
- Model / Reference
- 90121-5x0.5ML FDA UDI
- Description
- Polyvinylpyrrolidone (PVP) dissolved in mHTF (an isotonic HEPES buffered medium) to make a 7% (w/v) solution. Contains 5 mg/mL Human Serum Albumin. FDA UDI
Identifiers
- Catalog Number
- 90121 FDA UDI
- Primary DI / UDI-DI
- 00810195240125 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
Yes
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
7% PVP Solution with HSA by Irvine Scientific, Llc — 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
- Irvine Scientific, Llc
Sources (1)
- FDA UDI 6d2bc2eb-4356-4496-9fb6-0ddcf6624d7c 35 fields · synced May 30, 2026