Product code QOH

Device name
Extracorporeal System For Carbon Dioxide Removal
Medical specialty
Cardiovascular
Device class
2
Regulation number
870.4150
Review panel
CV
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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).
Source
FDA openFDA device classification dataset