Gems Geri Medium
Gems Geri Medium is used for in-vitro culture of embryos from fertilization through the blastocyst stage. It may also be used when transferring embryos into the uterus as part of assisted…
Gems Geri Medium is used for in-vitro culture of embryos from fertilization through the blastocyst stage. It may also be used when transferring embryos into the uterus as part of assisted reproduction procedures in a hospital setting.
The liquid culture medium contains salts, energy substrates, amino acids, buffering agents, nutrient supplements and antibiotics. It provides the surrounding culture environment while embryos develop, with Geri specifications of pH 7.4 to 7.6 and osmolality from 285 to 295mOsm/kg.
Listed Item
The Gems Geri Medium is intended for culture of embryos from fertilization to blastulation stage and transfer of embryos to the uterus.
Supply
The medium is supplied as a single-use product, aseptically filled into a sterilized bottle.
Who Else Makes It
Concentrated in Guangdong (3), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Shenzhen VitaVitro Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Gimbo Medical Technology Shenzhen Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
| Shandong Wego Ruisheng Medical Device Co., Ltd. | Weihai | Shandong | Manufacturer | 2 |
Record
| Listed by | Genea Biomedx Pty Ltd., Australia |
|---|---|
| FDA product code | MQL |
| Device type | Media, Reproductive |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6180 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K161261 |
| Record published | 2017-12-11 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Sizes | Total volume 50 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ONE-20 | In distribution | |
| ONE-50 | Total Volume 50 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LifeGlobal® Media | LifeGlobal Group, LLC | 93 |
| Sydney IVF | William A. Cook Australia PTY, Ltd. | 29 |
| LifeGlobal® Media | Coopersurgical, Inc. | 27 |
| VitaVitro | Shenzhen VitaVitro Biotech Co., Ltd. | 22 |
| Nidacon | Nidacon International AB | 19 |
| Sil-Select Plus Lower Layer | Fertipro NV | 8 |
| FertiCult Mineral Oil | Fertipro NV | 8 |
| Dewin | Donnevie Medical Technology (Shanghai) Co., Ltd. | 8 |
| SpermGrad | Vitrolife Sweden AB | 8 |
| Sequential Culture Media | Kitazato Corporation | 8 |
| Sperm Wash Medium | Invitrocare Inc | 7 |
| Enhance-S Plus | Vitrolife Inc. | 7 |
Showing 12 of 360. All products under Media, Reproductive
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170498 | 2017-09-28 |
| K162409 | 2017-05-24 |
| K161261 | 2017-05-12 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.