DreamStation 00
by Respironics Inc. 22 variants
DreamStation 00 (FRX400S14) is a Class II device made by Respironics Inc., listed in FDA GUDID since 29 Aug 2016 (UDI-DI 00606959023567), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00606959023567 | Date29 Aug 2016 | StatusListed |
Official records
- AccessGUDID record 00606959023567
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- DreamStation
- Generic name
- Home CPAP unit
- Model / Ref / Catalog
- 00, FRX400S14
- Primary DI / UDI-DI
- 00606959023567
- 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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