Device Dossier

Breathing circuit, ventilator, single use

Device Dossier for Breathing circuit, ventilator, single use (Breathing circuit, ventilator, single use, Class IIb, sponsor Draeger). ARTG record,…

Intended purpose

VentStar AutoBreath heated (N) with automatic PEEP valve is a disposable breathing circuit for conveying breathing gas from a breathing gas source (resuscitation module) via the Fisher & Paykel MR850 humidifier to a patient. The product allows automatic short-term ventilation with humidified breathing gas and additional PEEP. The valve is controlled via the AutoBreath function of the resuscitation module. The product can be connected to a breathing mask, a laryngeal mask, or an endotracheal tube via the patient port. The product is suitable for patients with a maximum body weight of 10 kg (22 lb).

TGA Public Summary