Last synced on 25 November 2022 at 11:04 pm

Ventilator Tubing And Accessories

Page Type
Product Code
Definition
Accessories used with non-continuous ventilators (may include Ventilator Tubing Connector, Elbow Connector for Mask, Breathing Attachment devices) for use 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 QOO is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Ventilator Tubing And Accessories

Page Type
Product Code
Definition
Accessories used with non-continuous ventilators (may include Ventilator Tubing Connector, Elbow Connector for Mask, Breathing Attachment devices) for use 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 QOO is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.