Portex 20-0004
Portex 20-0004 is an incentive spirometer (FDA Class II; FDA product code CAH, Filter, bacterial, breathing-circuit) made by ICU Medical, Inc., listed in FDA GUDID since 11 Oct 2016 (UDI-DI 10788942200043), 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 | Number10788942200043 | Date11 Oct 2016 | StatusListed |
Official records
- AccessGUDID record 10788942200043
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Portex
- Generic name
- Incentive spirometer
- Model / reference
- 20-0004
- Primary DI / UDI-DI
- 10788942200043
- FDA product code
- CAH
- GMDN term
- Incentive spirometer
- Device class
- Class II
- Regulation number
- 868.5260
- GUDID distribution status
- In Commercial Distribution
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