Device Dossier
Resuscitator, pulmonary, manual, single use
Device Dossier for Resuscitator, pulmonary, manual, single use (Resuscitator, pulmonary, manual, single use, Class IIa, sponsor Flexicare). ARTG record,…
- GMDN category: Resuscitator, pulmonary, manual, single use
Intended purpose
To be used 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.