QLN

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

产品代码

QLN

器械名称

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

管理类别

第 N 类（Not Classified）

FDA 专业组

Unknown

上市路径

EUA - Emergency Use Authorization

标记

属生命支持/维持器械

FDA 分类定义

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.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。