Level 1 L1-Shelf
Level 1 L1-Shelf is a portable active medical device mount (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 19 Mar 2019 (UDI-DI 15019517100273), 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 | Number15019517100273 | Date19 Mar 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181699 | Date26 Jul 2018 | StatusActive |
Official records
- AccessGUDID record 15019517100273
- FDA 510(k) database K181699
Across registries
- FDA 510(k) K181699 decided 26 Jul 2018 Active
- FDA GUDID UDI-DI 15019517100273 listed 19 Mar 2019 Listed
Timeline
- Cleared FDA 510(k) K181699
- Listed FDA GUDID 15019517100273
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Level 1
- Generic name
- Portable active medical device mount
- Model / reference
- L1-Shelf
- Primary DI / UDI-DI
- 15019517100273
- 510(k) Number
- FDA product code
- DWJ
- GMDN term
- Portable active medical device mount
- Device class
- Class II
- Regulation number
- 870.5900
- GUDID distribution status
- In Commercial Distribution
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