Level 1 L1-CW-120V
Level 1 L1-CW-120V is a medical device (FDA Class II; FDA product code DWJ, System, thermal regulating) 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 15019517121551), 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 | Number15019517121551 | Date17 Aug 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181699 | Date26 Jul 2018 | StatusActive |
Official records
- AccessGUDID record 15019517121551
- FDA 510(k) database K181699
Across registries
- FDA 510(k) K181699 decided 26 Jul 2018 Active
- FDA GUDID UDI-DI 15019517121551 listed 17 Aug 2018 Listed
Timeline
- Cleared FDA 510(k) K181699
- Listed FDA GUDID 15019517121551
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- Withdrawn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-CW-120V
- Primary DI / UDI-DI
- 15019517121551
- 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
Similar devices
Other devices filed under FDA product code DWJ (System, thermal regulating).
- LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM by Progressive Dynamics, Inc.
- HOTDOG MULTI FUNCTION CONTROLLER by Augustine Biomedical & Design, LLC
- AQUAMATIC K-77 by Gorman Rupp Industries
- 3M Bair Hugger Model 675 Total Temperature Management System by 3M COMPANY
- ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS by Medivance, Inc.
- THERMAL REGULATION SYSTEM BLANKET by Gibeck, Inc.
- BAIR HUGGER CUB BLANKET- SHORT MODEL 536 by Augustine Medical, Inc.
- CRITICOOL by Mtre Advanced Technology, Ltd.
- EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY by Smiths Medical Asd, Inc.
- BAIR HUGGER PATIENT WARMING SYSTEM by Augustine Medical, Inc.