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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device extracorporeal system for carbon dioxide removal
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).
Product CodeQOH
Regulation Number 870.4150
Device Class 2

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