Last synced on 24 June 2022 at 11:05 pm

Emergency Resuscitator

Page Type
Product Code
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.
Physical State
n/a
Technical Method
n/a
Target Area
n/a
Review Panel
Anesthesiology
Submission Type
EUA - Emergency Use Authorization
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code QOU is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Emergency Resuscitator

Page Type
Product Code
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.
Physical State
n/a
Technical Method
n/a
Target Area
n/a
Review Panel
Anesthesiology
Submission Type
EUA - Emergency Use Authorization
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code QOU is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.