Identity
- Trade Name
- Gems Blastocyst Medium FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- The Gems Blastocyst Medium is intended for culture of embryos from cleavage stage to blastulation stage and transfer of embryos to the uterus. FDA UDI
- Model / Reference
- BLM-20 FDA UDI
- Description
- The Gems Blastocyst Medium is intended for culture of embryos from cleavage stage to blastulation stage and transfer of embryos to the uterus. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348265005066 FDA UDI
- 510(k) Number
- K161261 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
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
Category: IVF medium
Gems Blastocyst Medium by Genea Biomedx Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K161261 also covers:
- Gems Blastocyst Medium — GENEA BIOMEDX PTY LTD
- Gems Cleavage Medium — GENEA BIOMEDX PTY LTD
- Gems Cleavage Medium — GENEA BIOMEDX PTY LTD
- Gems Fertilisation Medium — GENEA BIOMEDX PTY LTD
- Gems Fertilisation Medium — GENEA BIOMEDX PTY LTD
- Gems Geri Medium — GENEA BIOMEDX PTY LTD
- Gems Geri Medium — GENEA BIOMEDX PTY LTD
- Gems VitBase — GENEA BIOMEDX PTY 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
- Genea Biomedx Pty Ltd
Sources (1)
- FDA UDI 0cbc0482-ba60-4728-9c15-eafdda5e027b 34 fields · synced May 30, 2026