QOH

Extracorporeal System For Carbon Dioxide Removal

产品代码

QOH

器械名称

Extracorporeal System For Carbon Dioxide Removal

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 870.4150

FDA 专业组

Cardiovascular

上市路径

需提交 510(k) 上市前通告

该代码近三年的 510(k)

1 件

FDA 分类定义

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).

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）。