RapidVit Blast
RapidVit Blast is a set of media used to prepare human blastocyst stage embryos for vitrification. Its solutions reduce intracellular water and increase osmolality before cryopreservation.…
RapidVit Blast is a set of media used to prepare human blastocyst stage embryos for vitrification. Its solutions reduce intracellular water and increase osmolality before cryopreservation. The product is intended for this developmental stage within assisted reproduction procedures.
The set contains three solutions with progressively increasing cryoprotectant concentrations. Ethylene glycol and propanediol work with sucrose to dehydrate the embryo during preparation. The sequence changes the surrounding medium as the embryo moves toward vitrification conditions.
Buffering System
The media use a MOPS buffering system to maintain physiological pH during handling outside the incubator. Their composition is formulated for blastocysts rather than the earlier cleavage stage.
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) | K101003 |
| Record published | 2016-09-13 |
| Record revised | 2025-01-23 (version 5) |
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 |
|---|---|---|
| 10119 | 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.