Thawing Solution Add-On Pack
Thawing Solution Add-On Pack. Contains 5x2mL Thawing Solution-TS to be used with Vit-Kit Thaw.
4manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 90134-TPACK | 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.