FDA product code QOO: Ventilator Tubing And Accessories
QOO is the FDA product code for ventilator tubing and accessories. It is a Not classified device, reviewed by the Ear, Nose and Throat panel. Devices under QOO reach the market by PMA; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Ventilator Tubing And Accessories |
| Device class | Not classified |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QOO devices
openFDA lists no recalls for product code QOO.
Frequently asked questions
What is FDA product code QOO?
QOO is the FDA product code for ventilator tubing and accessories. It is a Not classified device, reviewed by the Ear, Nose and Throat panel.
What device class is QOO?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QOO
- Run a recall and safety report across every QOO manufacturer
- Watch product code QOO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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