V-Vitfreeze
V-Vitfreeze is a media kit for vitrification of mature oocytes, zygotes and embryos through the blastocyst stage in IVF. Its equilibration and vitrification solutions prepare the cells for…
V-Vitfreeze is a media kit for vitrification of mature oocytes, zygotes and embryos through the blastocyst stage in IVF. Its equilibration and vitrification solutions prepare the cells for cryopreservation.
Both media contain ethylene glycol and dimethyl sulfoxide, with trehalose added to the vitrification solution. Permeating cryoprotectants replace water before vitrification and storage in liquid nitrogen.
Listed Item
V-VITFREEZE is a ready-to-use kit to cryopreserve human oocytes and embryos (up to blastocyst stage) in Assisted Reproduction Technology (ART). There are in total 3 vials of pink solutions in the package: -1 vial of Equilibration Solution (ES), with a blue cap and label. – 2 vials of Vitrification Solution (VS), with green caps and labels. V-VITFREEZE is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Solution and Vial Format
The two media types are supplied in 2 mL polypropylene vials with polyethylene screw caps. The base medium contains salts, buffers, energy substrates and other supporting ingredients. Solutions are aseptically filtered, and the storage vials are sterilized by radiation.
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 | 2024-10-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| V-FS-KIT | 3 | 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.