Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastoc…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161261 FDA 510(k)
- FDA Product Code
- MQL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.6180 FDA 510(k)
- Regulation Number
- 884.6180 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, and Gems VitBase are reproductive culture media designed for in vitro fertilisation (IVF) and embryo culture. These sterile, liquid formulations support oocyte maturation, fertilisation, cleavage-stage development, and blastocyst formation, while Gems VitBase provides temporary storage for embryos. The media are tailored to replicate physiological conditions, including low-oxygen environments, to enhance embryo viability and developmental success.
Supplied as single-use solutions in 20 ml and 50 ml volumes, these media are intended for use in clinical embryology laboratories. They comply with FDA regulations (884.6180) and have received FDA 510(k) clearance (K161261). Sterility is maintained for single-use applications, and no MRI safety information is specified. Storage and handling must adhere to manufacturer guidelines to preserve product integrity.
Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase
Frequently asked questions
What are the Gems Geri Medium, Fertilisation Medium, Cleavage Medium, Blastocyst Medium, and VitBase used for in IVF procedures?
These media are designed to replicate physiological conditions during in vitro fertilisation (IVF) and embryo culture. The Gems Geri Medium supports oocyte maturation, the Fertilisation Medium facilitates fertilisation, the Cleavage Medium aids early embryo development, and the Blastocyst Medium promotes blastocyst formation. The Gems VitBase provides temporary storage for embryos, ensuring viability while maintaining optimal conditions. Each formulation is tailored to specific stages of embryo development to enhance success rates.
How are the Gems IVF media supplied, and what volumes are available?
The Gems IVF media are supplied as single-use, sterile liquid solutions in two volumes: 20 ml and 50 ml. This packaging ensures sterility and convenience for clinical embryology laboratories, where precise dosing and contamination control are critical for successful IVF procedures.
Are the Gems IVF media intended for single-use or reusable applications?
These media are explicitly designed for single-use applications only. The sterile packaging and formulation are optimized for one-time clinical use to prevent cross-contamination and maintain product integrity. Reuse is not recommended or supported by the manufacturer.
What storage and handling guidelines should be followed for the Gems IVF media?
While the exact storage instructions are provided by the manufacturer, adherence to standard clinical laboratory practices is essential. The media should be stored according to the specified conditions (typically refrigerated or at room temperature, as indicated on the packaging) to preserve their efficacy. Proper handling, including avoiding contamination and ensuring sealed integrity, is critical to maintaining the media’s performance for embryo culture and storage.
Do the Gems IVF media include any special features, such as low-oxygen support?
Yes, the Gems IVF media are formulated to replicate physiological conditions, including low-oxygen environments. This feature is particularly important for embryo culture, as it mimics the natural uterine environment, which can improve embryo viability and developmental success during IVF procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Gems®- 3rd Generation Culture Media - Genea Biomedx, Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems ..., Gems®: Growth media to assist embryo development
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161261 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Genea Biomedx Pty Ltd
- FDA Applicant
- Genea Biomedx Pty, Ltd.
Sources (1)
- FDA 510(k) K161261 24 fields · synced Oct 1, 2026