Identity
- Trade Name
- LifeGlobal® Media FDA UDI
- Generic Name
- IVF medium kit FDA UDI
- Device Name
- global Blastocyst Fast Freeze Thawing kit, 5ml vials.. FDA UDI
- Model / Reference
- GFT5-055 FDA UDI
- Description
- global Blastocyst Fast Freeze Thawing kit, 5ml vials.. FDA UDI
Identifiers
- Catalog Number
- GFT5-055 FDA UDI
- Primary DI / UDI-DI
- 00815965020914 FDA UDI
- 510(k) Number
- K092963 FDA UDI
- FDA Product Code
- MQL FDA UDI
- GMDN Term
- IVF medium kit 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
Yes
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 kit
LifeGlobal® Media by LifeGlobal Group, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as IVF medium kit.
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- ORIGIO Gradient 40/80 — Origio A/S · Class II
- Ultra-Fast Vitri — KITAZATO CORPORATION · Class II
- G-Vitri™ Warming media — Gimbo Medical Technology Shenzhen Co., Ltd. · Class II
- G-Vitri™ Vitrification media — Gimbo Medical Technology Shenzhen Co., Ltd. · Class II
- Vitrification Media(VS solution) — KITAZATO CORPORATION · Class II
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 f9ee1a0e-bffa-4e3e-aa29-9b3987ee23e4 37 fields · synced Jun 9, 2026