Identity
- Trade Name
- Gamete Buffer FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- Gamete Buffer, 125mL FDA UDI
- Model / Reference
- GB125 FDA UDI
- Description
- Gamete Buffer, 125mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06976438300088 FDA UDI
- 510(k) Number
- K234023 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
Gamete Buffer 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
K234023 also covers:
- Gamete Buffer — Gimbo Medical Technology Shenzhen Co., Ltd.
- Gamete Buffer — Gimbo Medical Technology Shenzhen Co., Ltd.
- Gamete Buffer — Gimbo Medical Technology Shenzhen Co., Ltd.
- Oocyte Flushing & Retrieval Medium — Gimbo Medical Technology Shenzhen Co., Ltd.
- Oocyte Flushing & Retrieval Medium — Gimbo Medical Technology Shenzhen Co., Ltd.
- Oocyte Flushing & Retrieval Medium — Gimbo Medical Technology Shenzhen Co., Ltd.
- Oocyte Flushing & Retrieval 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 |
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Manufacturer
- Manufacturer
- Gimbo Medical Technology Shenzhen Co., Ltd.
Sources (1)
- FDA UDI 838fb0e4-184d-4b88-b458-cb3857a94eb8 34 fields · synced May 30, 2026