Gems VitBase
Gems VitBase is a culture medium for briefly maintaining embryos during vitrification and warming procedures. It is used in a non-gassed environment within assisted-reproduction work in a…
Gems VitBase is a culture medium for briefly maintaining embryos during vitrification and warming procedures. It is used in a non-gassed environment within assisted-reproduction work in a hospital setting. Embryos may remain in the medium for a maximum of ten minutes.
The medium provides a defined liquid environment during this short handling period. Its specified pH is 7.3 to 7.5, with an osmolality of 295 to 305 milliosmoles per kilogram. These characteristics apply to VitBase rather than the other embryo-culture media in the Gems range.
Listed Item
The Gems VitBase is intended for culture of embryos (up to 10 minutes) during embryo vitrification/warming procedures.
Preparation and Supply
VitBase is a single-use medium aseptically filled into sterilized bottles. It does not contain gentamicin. The product specification requires no microbiological growth and sets an endotoxin limit below 0.4 endotoxin units per millilitre.
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 | 2017-05-23 |
| 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 20 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VBS-20 | Total Volume 20 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.