Device Dossier

Ventilator, adult

Device Dossier for Ventilator, adult (Ventilator, adult, Class IIb, sponsor Wiselink Group). ARTG record, intended purpose, GMDN category — compiled by…

Intended purpose

This product provides assisted ventilation and respiratory support, SpO2 and CO2 monitoring for adult, pediatric and neonatal patients. This product is intended to be used in ICU environments or for use during transport within professional healthcare facilities.The ventilator should only be operated by qualified professionals, clinical staff who have received appropriate training or other authorized personnel. This product is not intended for use in an MRI environment.

TGA Public Summary