Vitrification Warming Kit
SAGE Vitrification Warming Kit. ART-8030-A: 1x4 ml 1.0M Surose Warming Solution, ART-8030-B: 1x2 ml 0.5M Sucrose Warming Solution, ART-8030-C: 1x6 ml MOPS Solution.
4manufacturers in China registered for this device type
1catalogue number
10510(k) clearances naming this product code
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 | Origio A/S, Denmark |
|---|---|
| FDA product code | MQL |
| Device type | Media, Reproductive |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6180 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2017-03-28 |
| Record revised | 2018-09-25 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ART-8030 | 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 |
|---|---|
| K173624 | 2018-03-02 |
| K172197 | 2017-10-13 |
| K153267 | 2016-07-22 |
| K152932 | 2016-02-29 |
| K140317 | 2014-06-16 |
| K133912 | 2014-05-14 |
| K133387 | 2014-04-29 |
| K133707 | 2014-04-16 |
| K120136 | 2012-09-26 |
| K100367 | 2010-08-27 |
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.