BiWaze Cough

Primary DI

+B9652037351818214060

Basic UDI-DI Code

++B965203735181821406PD

Reference

2037351818-21406

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

ABMRC LLC

This product is used for assisting patients to clear retained bronchopulmonary secretions by gradually applying positive pressure to the airway, then rapidly shifting to a negative pressure. This rapid shift in pressure, via a facemask, mouthpiece, endotracheal or tracheostomy tube produces a high expiratory flow rate from the lungs, simulating a cough. 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. This device is intended for use in hospital institutional setting or in home on adult and paediatric patients.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).