Identity
- Trade Name
- Sperm Washing Medium with HSA FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- Modified HTF Medium with Human Serum Albumin (HSA). 500mL bottle. FDA UDI
- Model / Reference
- 9983-500ML FDA UDI
- Description
- Modified HTF Medium with Human Serum Albumin (HSA). 500mL bottle. FDA UDI
Identifiers
- Catalog Number
- 9983 FDA UDI
- Primary DI / UDI-DI
- 00810195240804 FDA UDI
- 510(k) Number
- K983588 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
No
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
Sperm Washing Medium with HSA by Irvine Scientific, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K983588 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
- Irvine Scientific, Llc
Sources (1)
- FDA UDI d0d0cfd9-8f50-46e6-9165-91fadc57ad80 36 fields · synced May 30, 2026