QLD

Protective Barrier Enclosure

产品代码: QLD
器械名称: Protective Barrier Enclosure
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 transparent device designed to cover a patient's head and upper body and incorporates one or more ports through which the HCP's hands are passed to perform medical procedures. Device provides extra layer of barrier protection, in addition to PPE, during the 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： QLD

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。