Identity
- Trade Name
- Hy-GeneTM Seminal Fluid Collection Kit FDA UDI
- Generic Name
- Semen specimen collection container FDA UDI
- Device Name
- Specimen Collection Container for the collection of semen. FDA UDI
- Model / Reference
- ACK-121 FDA UDI
- Description
- Specimen Collection Container for the collection of semen. FDA UDI
Identifiers
- Catalog Number
- ACK-121 FDA UDI
- Primary DI / UDI-DI
- 00862242000305 FDA UDI
- 510(k) Number
- K954791 FDA UDI
- FDA Product Code
- HIS FDA UDI
- GMDN Term
- Semen specimen collection container FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5300 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
No
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: Semen specimen collection container
Hy-GeneTM Seminal Fluid Collection Kit by Apex Medical Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K954791 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
- Apex Medical Technologies, Inc.
Sources (1)
- FDA UDI e7c79606-6e84-4aa7-ba71-abb95e86f85b 37 fields · synced May 31, 2026