Portex 21-5015
Portex 21-5015 is a Class II device made by ICU Medical, Inc., listed in FDA GUDID since 11 Oct 2016 (UDI-DI 10788942250154), 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 | Number10788942250154 | Date11 Oct 2016 | StatusListed |
Official records
- AccessGUDID record 10788942250154
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Portex
- Generic name
- Positive pressure airway secretion-clearing device
- Model / reference
- 21-5015
- Primary DI / UDI-DI
- 10788942250154
- FDA product code
- BWF
- GMDN term
- Positive pressure airway secretion-clearing device
- Device class
- Class II
- Regulation number
- 868.5690
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code BWF (SPIROMETER, THERAPEUTIC (INCENTIVE)).
- AEROBICA - LUNG EXERCISER by MBA Healthcare Products, Inc.
- MONAGHAN'S TRUE VOLUME EXERCISER by MONAGHAN MEDICAL CORP.
- OHIO VOLUME INCENTIVE SPIROMETER by Airco/Ohio Medical Products
- FLOW REDUCING ANGULATION STAND by Chesebrough-Pond'S U.S.A. Co.
- INSPIROMETER by Kinetix
- BUNN VOLUMAIRE RESPIRATORY EXERCISER by The John Bunn Co.
- PARI PEP THERAPY SYSTEM by Pari Holding Co.
- THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT by Diemolding Corp.
- K-MED ENCOURAGER INCENTIVE SPIROMETER by K-Med, Inc.
- INSPIRATORY/EXPIRATORY MUSCLE EXERCIS by Inspiron Corp.