Non-Continuous Ventilator for Emergency Use
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Guangdong.
- Resvent Medical Technology Co., Ltd. Guangdong, contract manufacturer
What Is It?
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.
What Is FDA Product Code QOQ?
Non-Continuous Ventilator For Emergency Use is FDA product code QOQ, not classified.
What Does It Take to Sell It in the United States?
This code was created for emergency use authorisation during the COVID-19 public health emergency; sale under it depended on the authorisation, not on a standard premarket submission.
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