This device is designed for use on patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow, resulting from high spinal cord injuries,…
This device is designed for use on patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow, resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient’s endotracheal tube or tracheostomy tube. For use in hospital, institutional setting, or at home. For use on adult patients and paediatric patients 3 years old and up.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for BiWaze Cough | Listed by | Abmrc LLC, United States |
| FDA product code | NHJ |
| Device type | Device, Positive Pressure Breathing, Intermittent |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2023-01-02 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | serial number |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.