Eclipse Starter Kit 100589
by Bleep, LLC
Eclipse Starter Kit 100589 is a home CPAP unit (FDA Class II; FDA product code BZD, Ventilator, Non-Continuous (Respirator)) made by Bleep, LLC, cleared under FDA 510(k) K172335 on 30 Mar 2018 and listed in FDA GUDID since 23 Aug 2022 (UDI-DI 00850003157122), 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 | Number00850003157122 | Date23 Aug 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK172335 | Date30 Mar 2018 | StatusActive |
Official records
- AccessGUDID record 00850003157122
- FDA 510(k) database K172335
Across registries
- FDA 510(k) K172335 decided 30 Mar 2018 Active
- FDA GUDID UDI-DI 00850003157122 listed 23 Aug 2022 Listed
Timeline
- Cleared FDA 510(k) K172335
- Listed FDA GUDID 00850003157122
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Eclipse Starter Kit
- Generic name
- Home CPAP unit
- Model / reference
- 100589
- Primary DI / UDI-DI
- 00850003157122
- 510(k) Number
- FDA product code
- BZD
- GMDN term
- Home CPAP unit
- Device class
- Class II
- Regulation number
- 868.5905
- GUDID distribution status
- In Commercial Distribution
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