Identity
- Trade Name
- Giftlife™ Fertilization Medium FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- Giftlife™ Fertilization Medium, 30mL FDA UDI
- Model / Reference
- FM30 FDA UDI
- Description
- Giftlife™ Fertilization Medium, 30mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06976438300125 FDA UDI
- 510(k) Number
- K240149 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
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
Yes
FDA UDI
Category: IVF medium
Giftlife™ Fertilization Medium by Gimbo Medical Technology Shenzhen Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K240149 also covers:
- Giftlife™ Blastocyst Medium — Gimbo Medical Technology Shenzhen Co., Ltd.
- Giftlife™ Blastocyst Medium — Gimbo Medical Technology Shenzhen Co., Ltd.
- Giftlife™ Blastocyst Medium — Gimbo Medical Technology Shenzhen Co., Ltd.
- Giftlife™ Cleavage Medium — Gimbo Medical Technology Shenzhen Co., Ltd.
- Giftlife™ Cleavage Medium — Gimbo Medical Technology Shenzhen Co., Ltd.
- Giftlife™ Cleavage Medium — Gimbo Medical Technology Shenzhen Co., Ltd.
- Giftlife™ Fertilization Medium — Gimbo Medical Technology Shenzhen Co., Ltd.
- Giftlife™ Fertilization Medium — Gimbo Medical Technology Shenzhen Co., Ltd.
- Giftlife™ Single Step Medium — Gimbo Medical Technology Shenzhen Co., Ltd.
- Giftlife™ Single Step Medium — Gimbo Medical Technology Shenzhen Co., Ltd.
- Giftlife™ Single Step Medium — Gimbo Medical Technology Shenzhen Co., Ltd.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gimbo Medical Technology Shenzhen Co., Ltd.
Sources (1)
- FDA UDI 896da6c0-4782-48c2-900b-a78c97cce3f7 34 fields · synced Jun 8, 2026