FreezeKit Cleave
FreezeKit Cleave is a culture-media kit for freezing pronuclear, two-pronuclei and cleavage-stage embryos during in vitro fertilisation. It contains two solutions for the embryo-freezing…
FreezeKit Cleave is a culture-media kit for freezing pronuclear, two-pronuclei and cleavage-stage embryos during in vitro fertilisation. It contains two solutions for the embryo-freezing process.
The solutions use a MOPS-buffered formulation containing human serum albumin, hyaluronan and gentamicin as an antibacterial agent. The freezing solution includes 1,2-propanediol and sucrose as cryoprotectants.
Companion Kit
FreezeKit Cleave is marketed separately from ThawKit Cleave. The two kits are recommended for use together for freezing and subsequent thawing, with each kit serving its stated stage of the process.
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 | Vitrolife Sweden AB, Sweden |
|---|---|
| FDA product code | MQL |
| Device type | Media, Reproductive |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6180 |
| Establishment | Manufacturer |
| 510(k) | K150950 |
| Record published | 2018-02-20 |
| Record revised | 2025-01-23 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10169 | 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 |
|---|---|
| K240605 | 2024-08-07 |
| K202862 | 2021-05-14 |
| K183486 | 2019-07-26 |
| K150950 | 2015-12-21 |
| K113786 | 2012-10-26 |
| K101003 | 2010-12-10 |
| K080446 | 2008-11-26 |
| K081115 | 2008-09-17 |
| K081114 | 2008-09-16 |
| K081117 | 2008-09-16 |
| K081116 | 2008-09-02 |
| K043116 | 2005-01-13 |
| K033101 | 2004-05-07 |
| K032877 | 2004-05-07 |
| K031015 | 2003-06-23 |
| K023403 | 2002-12-13 |
| K022295 | 2002-09-12 |
| K022244 | 2002-09-06 |
| K021896 | 2002-09-06 |
| K021894 | 2002-09-06 |
| K022247 | 2002-09-06 |
| K021890 | 2002-09-06 |
| K021893 | 2002-09-06 |
| K022245 | 2002-09-06 |
| K991348 | 2000-05-17 |
| K991351 | 2000-02-25 |
| K991346 | 2000-02-24 |
| K991345 | 2000-02-18 |
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.