Last synced on 24 June 2022 at 11:05 pm

Ventilatory Assistance Helmet

Page Type
Product Code
Definition
Patient interface for delivery of positive pressure to assist patient's breathing during declared public health emergency. Can be used with continuous and non-continuous ventilators, wall gas source, oxygen source, humidified gases.
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 QOW is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Ventilatory Assistance Helmet

Page Type
Product Code
Definition
Patient interface for delivery of positive pressure to assist patient's breathing during declared public health emergency. Can be used with continuous and non-continuous ventilators, wall gas source, oxygen source, humidified gases.
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 QOW is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.