BiliSoft Phototherapy System BI2
BiliSoft Phototherapy System BI2 is an overhead infant phototherapy unit (FDA Class II; FDA product code LBI, Unit, Neonatal Phototherapy) made by Datex-Ohmeda Inc., cleared under FDA 510(k) K053568 on 17 Apr 2006 and listed in FDA GUDID since 24 Jun 2016 (UDI-DI 00840682116534), 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 | Number00840682116534 | Date24 Jun 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK053568 | Date17 Apr 2006 | StatusActive |
Official records
- AccessGUDID record 00840682116534
- FDA 510(k) database K053568
Across registries
- FDA 510(k) K053568 decided 17 Apr 2006 Active
- FDA GUDID UDI-DI 00840682116534 listed 24 Jun 2016 Listed
Timeline
- Cleared FDA 510(k) K053568
- Listed FDA GUDID 00840682116534
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BiliSoft Phototherapy System
- Generic name
- Overhead infant phototherapy unit
- Model / reference
- BI2
- Primary DI / UDI-DI
- 00840682116534
- 510(k) Number
- FDA product code
- LBI
- GMDN term
- Overhead infant phototherapy unit
- Device class
- Class II
- Regulation number
- 880.5700
- GUDID distribution status
- In Commercial Distribution
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- Neoblue 019030 by Natus Medical Denmark ApS
- Lullaby LED Phototherapy System by Datex-Ohmeda Inc.