Device Dossier

Ventilator, adult

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

Intended purpose

The Evita intensive care ventilator (Evita V800 / Evita V600) is intended for the ventilation of adults with an IBW of 31.7 kg (70 lb) to 137.5 kg (303 lb), pediatric patients with an IBW of 5.2 kg (11.5 lb) to 49.6 kg (109 lb), and neonates with a body weight of 0.4 kg (0.88 lb) to 10 kg (22 lb). This device provides mandatory ventilation modes and ventilation modes for supporting spontaneous breathing as well as ventilation monitoring.

TGA Public Summary