Identity
- Trade Name
- mHTF FDA UDI
- Generic Name
- Cell culture medium IVD FDA UDI
- Device Name
- 1-(500mL) FDA UDI
- Model / Reference
- 15227 FDA UDI
- Description
- 1-(500mL) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00805360016551 FDA UDI
- 510(k) Number
- K023655 FDA UDI
- FDA Product Code
- MQL FDA UDI
- GMDN Term
- Cell culture medium IVD 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
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
Dimensions & Sizes
- Size
- Total Volume — 500 Milliliter FDA UDI
Category: Cell culture medium IVD
mHTF by Vitrolife AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K023655 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
- Vitrolife AB
Sources (1)
- FDA UDI 40f0a356-367c-4598-88ab-4f33c1957c74 35 fields · synced Jun 1, 2026