AeroWrap™ Flex Extra Large Extra Large Flex
AeroWrap Flex Extra Large Extra Large Flex (MS-XLF) is a sequential venous compression system (FDA Class I; FDA product code MHW, Dressing, Compression) made by Sun Scientific, cleared under FDA 510(k) K070457 on 16 May 2007 and listed in FDA GUDID since 15 Apr 2022 (UDI-DI 00856525007310), active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00856525007310 | Date15 Apr 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK070457 | Date16 May 2007 | StatusActive |
Official records
- AccessGUDID record 00856525007310
- FDA 510(k) database K070457
Across registries
- FDA 510(k) K070457 decided 16 May 2007 Active
- FDA GUDID UDI-DI 00856525007310 listed 15 Apr 2022 Listed
Timeline
- Cleared FDA 510(k) K070457
- Listed FDA GUDID 00856525007310
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AeroWrap™ Flex Extra Large
- Generic name
- Sequential venous compression system
- Model / Ref / Catalog
- Extra Large Flex, MS-XLF
- Primary DI / UDI-DI
- 00856525007310
- 510(k) Number
- FDA product code
- MHW
- GMDN term
- Sequential venous compression system
- Device class
- Class I
- Regulation number
- 880.5075
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code MHW (Dressing, Compression).