Identifiers
- 510(k) Number
- K240605 FDA 510(k)
- FDA Product Code
- MQL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.6180 FDA 510(k)
- Regulation Number
- 884.6180 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ultra Rapidwarm Blast is a medium for ultra-fast warming of vitrified human blastocyst-stage embryos. It is used in the field of Obstetrics/Gynecology. The device is classified as a class 2 medical device. It works with all cleared vitrification solutions and devices.
The Ultra Rapidwarm Blast is supplied ready to use after warming to 37 °C in ambient atmosphere. It should be stored in the dark at +2 to +8°C and can be used for up to 2 weeks after first opening. The device has been cleared under FDA 510(k) number K240605.
Frequently asked questions
What is the Ultra RapidWarm Blast used for?
The Ultra RapidWarm Blast is used for ultra-fast warming of vitrified human blastocyst-stage embryos in the field of Obstetrics/Gynecology.
How is the Ultra RapidWarm Blast supplied?
The Ultra RapidWarm Blast is supplied ready to use after warming to 37 °C in ambient atmosphere.
How should the Ultra RapidWarm Blast be stored?
The Ultra RapidWarm Blast should be stored in the dark at +2 to +8°C and can be used for up to 2 weeks after first opening.
Is the Ultra RapidWarm Blast compatible with other devices?
The Ultra RapidWarm Blast works with all cleared vitrification solutions and devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ultra RapidWarm™ Blast - Vitrolife, PDF Ultra RapidWarm™ Bla - vitrolife.com, K240605 FDA 510(k) - Ultra RapidWarm Blast | Vitrolife Sweden AB
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240605 | Class II | Active |
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Manufacturer
- Manufacturer
- Vitrolife Sweden AB
Sources (1)
- FDA 510(k) K240605 24 fields · synced Sep 27, 2026