Vitrification Thaw Kit (Vit Kit-Thaw) With Gentamicin and DSS
Vit Kit-Thaw provides culture media for thawing and recovering vitrified human oocytes and embryos during assisted reproduction. Its three solutions are used in sequence for mature oocytes,…
Vit Kit-Thaw provides culture media for thawing and recovering vitrified human oocytes and embryos during assisted reproduction. Its three solutions are used in sequence for mature oocytes, pronuclear zygotes, cleavage-stage embryos through day three and blastocysts. The media are used outside the body.
The kit contains thawing, dilution and washing solutions based on modified HEPES-buffered Medium 199. The formulation includes dextran substitute supplement and gentamicin. Sucrose concentrations differ between the thawing and dilution stages to support the staged recovery process.
Listed Item
Vitrification Thaw Kit (Vit Kit-Thaw) with Gentamicin and DSS. Includes 8x2mL Vials Thawing Solution-TS (yellow cap), 5x2mL Vials Dilution Solution-DS (orange cap) and 5x2mL Vials Washing Solution-WS (red cap).
Sequential Solutions
The thawing solution contains 1.0 M sucrose and the dilution solution contains 0.5 M sucrose. These solutions are followed by washing medium. The thaw kit is used for warming and recovery rather than for the initial vitrification step.
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 | Irvine Scientific LLC, United States |
|---|---|
| FDA product code | MQL |
| Device type | Media, Reproductive |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6180 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K160006 |
| Record published | 2025-06-02 |
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 |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 90137-SO | In distribution | |
| 90137-DSOC | 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 |
|---|---|
| K160006 | 2016-05-04 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Fujifilm Biosciences Inc. | 510(k) number | 2021-09-08 | Class II | Software design | Due to a component in kit being labeled with the incorrect Expiration Date | 677 units or kits of 90133-DSOC210605 (9 x 1ml per kit); 595 |
| Fujifilm Biosciences Inc. | 510(k) number | 2021-09-08 | Class II | Software design | Due to a component in kit being labeled with the incorrect Expiration Date | 3981 units of Vitrification Freeze Kit 90133-SO210605; 314 k |
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.