FDA product code QOH: Extracorporeal System For Carbon Dioxide Removal

QOH is the FDA product code for extracorporeal system for carbon dioxide removal. It is a Class II device, regulated under 21 CFR 870.4150 and reviewed by the Cardiovascular panel. Devices under QOH reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

Definition

An extracorporeal system for carbon dioxide removal is a system of devices and accessories that provides assisted extracorporeal carbon dioxide removal from the patient's blood in patients with acute respiratory failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The main devices and accessories of the system include, but are not limited to, the console (hardware), software, and disposables, including, but not limited to, a gas exchanger, blood pump, cannulae, tubing, filters, and other accessories (e.g., monitors, detectors, sensors, connectors).

Classification

Recalls for QOH devices

openFDA lists no recalls for product code QOH.

Frequently asked questions

What is FDA product code QOH?

QOH is the FDA product code for extracorporeal system for carbon dioxide removal. It is a Class II device, regulated under 21 CFR 870.4150 and reviewed by the Cardiovascular panel.

What device class is QOH?

Class II, regulation 21 CFR 870.4150. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code QOH
• Run a recall and safety report across every QOH manufacturer
• Watch product code QOH 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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