Identity
- Trade Name
- V-SPERM WASH FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- V-SPERM WASH is an assisted reproduction medium intended for washing ofspermatozoa, the isolation of motile viable sperm by swim-up method and holdingsperm for IUI procedure. FDA UDI
- Model / Reference
- V-SWM-100 FDA UDI
- Description
- V-SPERM WASH is an assisted reproduction medium intended for washing ofspermatozoa, the isolation of motile viable sperm by swim-up method and holdingsperm for IUI procedure. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260650070105 FDA UDI
- 510(k) Number
- K223117 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
V-Sperm Wash by VITROMED GmbH — 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
- VITROMED GmbH
Sources (1)
- FDA UDI 931c4785-f882-4bc0-b009-926ce654e52d 34 fields · synced May 30, 2026