Device Dossier
Ventilator, adult
Device Dossier for Ventilator, adult (Ventilator, adult, Class IIb, sponsor Hospital Products). ARTG record, intended purpose, GMDN category — compiled…
- GMDN category: Ventilator, adult
Intended purpose
The Ventilator is intended to provide ventilation assistance and breath support for adult, pediatric and infant patients with respiratory insufficiency or respiratory failure in the hospital or other medical institutions. Ventilation may be delivered via mask or tracheotomy. This product must be operated by doctors, respiration therapist or other specially trained and authorized personnel. Anyone unauthorized or untrained must not perform any operation on it.