Device Dossier
Resuscitator, pulmonary, manual, single use
Device Dossier for Resuscitator, pulmonary, manual, single use (Resuscitator, pulmonary, manual, single use, Class IIa, sponsor Multigate Medical…
- GMDN category: Resuscitator, pulmonary, manual, single use
Intended purpose
A single-use device intended to provide or assist ventilation in patients who exhibit inadequate respiration. The device may be used in ambulances, emergency rooms, or intensive care areas throughout hospitals. It may includes an oxygen reservoir, mask, and tubing for connection to an oxygen line.