I neb 00
by Respironics Respiratory Drug Delivery (UK) Ltd
I neb 00 (1083220) is an ultrasonic nebulizing system (FDA Class II; FDA product code CAF, Nebulizer (Direct Patient Interface)) made by Respironics Respiratory Drug Delivery (UK) Ltd, listed in FDA GUDID since 24 Aug 2016 (UDI-DI 00383730000909), 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 | Number00383730000909 | Date24 Aug 2016 | StatusListed |
Official records
- AccessGUDID record 00383730000909
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- I neb
- Generic name
- Ultrasonic nebulizing system
- Model / Ref / Catalog
- 00, 1083220
- Primary DI / UDI-DI
- 00383730000909
- FDA product code
- CAF
- GMDN term
- Ultrasonic nebulizing system
- Device class
- Class II
- Regulation number
- 868.5630
- GUDID distribution status
- In Commercial Distribution
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