Non-Continuous Ventilator For Emergency Use
The Non-Continuous Ventilator for Emergency Use is a device that delivers intermittent positive pressure breathing (IPPB) to deliver aerosol to a patient's lungs or to assist breathing, intended for use during a declared public health emergency. Authorized under an FDA EUA, it is not formally classified by device class. Product code QOQ, reviewed by the Anesthesiology panel. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QOQ
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- AN
- Submission Type
- 8
Device Characteristics
Definition
A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing for use during declared public health emergency.
Unclassified Reason
11
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.