Device Dossier

Ventilator, neonatal/paediatric

Device Dossier for Ventilator, neonatal/paediatric (Ventilator, neonatal/paediatric, Class IIb, sponsor Emergo). ARTG record, intended purpose, GMDN…

Intended purpose

A device providing automatic cycling used to assist/control alveolar ventilation by delivering an appropriate volume of gas to the respiratory airways. Respiratory gases are delivered to the patient's airway through a mouthpiece, mask, or endotracheal tube. The device provides respiratory support to neonates and paediatric patients in intensive care units and for transport and includes high frequency oscillation and the delivery of nitric oxide and other special applications that pertain to specific clinical conditions. The device is used with breathing circuits and may be used with airway monitoring devices.

TGA Public Summary