QLN

Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19

Product code

QLN

Device name

Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19

Device class

Class N

Medical specialty

Unknown

Marketing pathway

EUA - Emergency Use Authorization

Flag

Life-sustaining / life-supporting

FDA classification definition

to treat lung failure due to COVID-19 when used as an adjunct to noninvasive or invasive mechanical ventilation in reducing hypercapnia and hypercapnic acidosis due to Coronavirus Disease 2019 (COVID-19), and/or maintaining normalized levels of partial pressure of carbon dioxide (PCO2) and pH in patients suffering from acute, reversible respiratory failure due to COVID-19 for whom ventilation of CO2 cannot be adequately, safely, or tolerably achieved.

Definition text from the FDA device classification database (U.S. federal government work, public domain).