Last synced on 2 December 2022 at 11:04 pm

Respiratory Humidifier For Emergency Use

Page Type
Product Code
Definition
Intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device 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 QOP is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Respiratory Humidifier For Emergency Use

Page Type
Product Code
Definition
Intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device 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 QOP is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.