Gems Blastocyst Medium
Gems Blastocyst Medium is an embryo culture medium used in assisted reproduction in a hospital environment. It supports in vitro culture from the cleavage stage to the blastocyst stage of…
Gems Blastocyst Medium is an embryo culture medium used in assisted reproduction in a hospital environment. It supports in vitro culture from the cleavage stage to the blastocyst stage of development and can also be used when transferring blastocyst stage embryos to the uterus.
It is supplied as a single-use medium in aseptically filled, sterilized bottles. The culture media range contains salts, energy substrates, amino acids, buffering agents, nutrient supplements and antibiotics.
Listed Item
The Gems Blastocyst Medium is intended for culture of embryos from cleavage stage to blastulation stage and transfer of embryos to the uterus.
Medium Specifications
Gems Blastocyst Medium has a specified pH range of 7.6 to 7.8 and an osmolality range of 285 to 295 mOsm/kg. These specifications apply to the blastocyst formulation.
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 50 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BLM-50 | Total Volume 50 ml | In distribution |
| BLM-20 | 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.