Identity
- Trade Name
- Human Tubal Fluid (HTF) Medium with Gentamicin FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- HTF Medium is a synthetic, defined solution for use as a culture media through Day 3 of human embryo development as well as the processing of gametes. HTF is bicarbonate-based and is designed for use in a CO2 incubator. HTF contains the antibiotic Gentamicin Sulphate. FDA UDI
- Model / Reference
- 90125-100ML FDA UDI
- Description
- HTF Medium is a synthetic, defined solution for use as a culture media through Day 3 of human embryo development as well as the processing of gametes. HTF is bicarbonate-based and is designed for use in a CO2 incubator. HTF contains the antibiotic Gentamicin Sulphate. FDA UDI
Identifiers
- Catalog Number
- 90125 FDA UDI
- Primary DI / UDI-DI
- 00810195240415 FDA UDI
- 510(k) Number
- K983586 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
Human Tubal Fluid (HTF) Medium with Gentamicin 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 718169d9-bd36-4f9c-bd92-d2c06800b542 36 fields · synced Jun 1, 2026