Ultra RapidWarm Blast
Ultra RapidWarm Blast is a medium for warming vitrified human blastocyst-stage embryos. It uses a single MOPS-buffered solution containing sucrose, human serum albumin and gentamicin. The…
Ultra RapidWarm Blast is a medium for warming vitrified human blastocyst-stage embryos. It uses a single MOPS-buffered solution containing sucrose, human serum albumin and gentamicin.
The medium is aseptically filtered into 5 mL PETG bottles with high-density polyethylene closures and a tamper-evident seal. The single-solution warming procedure uses a 250 mM sucrose formulation for two minutes.
Embryo Stage
The intended application is warming at the blastocyst stage. The solution is stored protected from light at 2 to 8°C, maintaining the specified handling conditions before use.
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) | K240605 |
| Record published | 2024-09-16 |
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 | Per pack | Status |
|---|---|---|---|
| 10150 | 4 | 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.