Device Dossier

BiWaze Cough Dual Lumen Circuit - Breathing circuit, ventilator, reusable

Device Dossier for BiWaze Cough Dual Lumen Circuit - Breathing circuit, ventilator, reusable (Breathing circuit, ventilator, reusable, Class IIa, sponsor…

Intended purpose

The BiWaze Cough Dual Lumen Breathing Circuit is an accessory designed for use with the BiWaze Cough device. It comprises coaxial breathing tubing, a coaxial B/V filter, and various patient interfaces, including facemasks, mouthpieces, and trach adapters. This breathing circuit is intended for single-patient use for a maximum duration of 30 days or up to 90 therapy cycles, whichever comes first, and connects to the BiWaze Cough System to deliver the therapy.

TGA Public Summary