Last synced on 2 December 2022 at 11:04 pm

Critical Care Ventilator

Page Type
Product Code
Definition
A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas during emergency and/or transfer use. Device is intended to be used temporarily and/or in emergency situations during declared public health emergency.
Physical State
n/a
Technical Method
n/a
Target Area
n/a
Review Panel
Ear, Nose, Throat
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 QOV is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Critical Care Ventilator

Page Type
Product Code
Definition
A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas during emergency and/or transfer use. Device is intended to be used temporarily and/or in emergency situations during declared public health emergency.
Physical State
n/a
Technical Method
n/a
Target Area
n/a
Review Panel
Ear, Nose, Throat
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 QOV is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.