V-Vitwarm
V-VITWARM is a set of media used to thaw vitrified human oocytes and embryos during IVF procedures. Thawing, diluent and washing solutions are used in sequence to warm the sample and remove…
V-VITWARM is a set of media used to thaw vitrified human oocytes and embryos during IVF procedures. Thawing, diluent and washing solutions are used in sequence to warm the sample and remove cryoprotectants.
The kit covers mature oocytes, pronuclear zygotes, cleavage-stage embryos through day three and blastocysts. The media contain a buffered base with salts, nutrients and supporting components; trehalose is included in the thawing and diluent solutions.
Listed Item
V VITWARM is a ready-to-use kit to thaw human oocytes and embryos (up to blastocyst stage) which are cryopreserved. Subsequently, the thawed oocytes and embryos can be used in Assisted Reproduction Technology (ART) processes. There are in total 4 vials of pink solutions in the package: – 2 vials of Thawing Solution (TS), with red caps and labels. – 1 vial of Diluent Solution (DS), with a yellow cap and label. – 1 vial of Washing Solution (WS), with a white cap and label. V-VITWARM is intended for use in the thawing of vitrified of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Laboratory Supply
The solutions are aseptically filtered and supplied in capped polypropylene vials. V-VITWARM is the thawing system, distinct from the V-VITFREEZE equilibration and vitrification media used before frozen storage.
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 | Vitromed GmbH, Germany |
|---|---|
| FDA product code | MQL |
| Device type | Media, Reproductive |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6180 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K240176 |
| Record published | 2024-11-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| V-TS-KIT | 4 | 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 |
|---|---|
| K241833 | 2025-03-21 |
| K240176 | 2024-09-13 |
| K232125 | 2024-03-20 |
| K222606 | 2023-05-26 |
| K223117 | 2023-01-31 |
| K193285 | 2020-11-20 |
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.