Product code QOU

Device name

Emergency Resuscitator

Medical specialty

Unknown

Device class

N

Review panel

AN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

Emergency ventilator incorporating bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway (may be automated) for use during declared public health emergency.

Source

FDA openFDA device classification dataset