Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19
QLN · Not classified · Unknown
Classification
FDA Product Code
QLN
Device class
Not classified
Regulation
—
Review panel
CV
Medical specialty
Unknown
Submission type
8
GMP exempt
N
Life sustaining
Y
Implant
N
Third-party review
N
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.