Level 1 L1-PWR-B
Level 1 L1-PWR-B is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K181699 on 26 Jul 2018 and listed in FDA GUDID since 17 Aug 2018 (UDI-DI 15019517100457), active as of 23 Oct 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 | Number15019517100457 | Date17 Aug 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181699 | Date26 Jul 2018 | StatusActive |
Official records
- AccessGUDID record 15019517100457
- FDA 510(k) database K181699
Across registries
- FDA 510(k) K181699 decided 26 Jul 2018 Active
- FDA GUDID UDI-DI 15019517100457 listed 17 Aug 2018 Listed
Timeline
- Cleared FDA 510(k) K181699
- Listed FDA GUDID 15019517100457
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Level 1
- Generic name
- Circulating-air whole-body heating system control unit
- Model / Ref / Catalog
- L1-PWR-B
- Primary DI / UDI-DI
- 15019517100457
- 510(k) Number
- FDA product code
- DWJ
- GMDN term
- Circulating-air whole-body heating system control unit
- Device class
- Class II
- Regulation number
- 870.5900
- GUDID distribution status
- In Commercial Distribution
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