Device Dossier

Resuscitator, pulmonary, manual, reusable

Device Dossier for Resuscitator, pulmonary, manual, reusable (Resuscitator, pulmonary, manual, reusable, Class IIa, sponsor Flexicare). ARTG record,…

Intended purpose

To be used to provide or assist ventilation in patients who are apneic or exhibit inadequate respiration. The device may be used in ambulances, emergency rooms, or intensive care areas throughout hospitals. Includes an oxygen reservoir, mask, and tubing for connection to an oxygen line.

TGA Public Summary