QLE

Protective Barrier Enclosure With Negative Pressure

产品代码: QLE
器械名称: Protective Barrier Enclosure With Negative Pressure
管理类别: 第 N 类（Not Classified）
FDA 专业组: Unknown
上市路径: EUA - Emergency Use Authorization

FDA 分类定义

A barrier device with negative pressure which partially or fully covers a patient to prevent HCP exposure to pathogenic biological airborne particulates. These barrier devices include ports for medical care and/or procedures. Device intended to be used during declared public health emergency.

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）。

FDA 官方分类页： QLE

分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。