Identity
- Trade Name
- LifeGlobal® Media FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- HTF w/ HEPES 250 ml FDA UDI
- Model / Reference
- GMHH-250 FDA UDI
- Description
- HTF w/ HEPES 250 ml FDA UDI
Identifiers
- Catalog Number
- GMHH-250 FDA UDI
- Primary DI / UDI-DI
- 00815965020150 FDA UDI
- 510(k) Number
- K040530 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
- Not 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
LifeGlobal® Media by LifeGlobal Group, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K040530 also covers:
- LifeGlobal® Media — LifeGlobal Group, LLC
- LifeGlobal® Media — LifeGlobal Group, LLC
- LifeGlobal® Media — LifeGlobal Group, LLC
- LifeGlobal® Media — LifeGlobal Group, LLC
- LifeGlobal® Media — LifeGlobal Group, LLC
- LifeGlobal® Media — LifeGlobal Group, LLC
- LifeGlobal® Media — LifeGlobal Group, LLC
- LifeGlobal® Media — LifeGlobal Group, LLC
- LifeGlobal® Media — LifeGlobal Group, LLC
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
- LifeGlobal Group, LLC
Sources (1)
- FDA UDI 843e542e-bced-4739-a9f0-d81c8f53053f 38 fields · synced Jun 9, 2026