SGX

Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves

产品代码

SGX

器械名称

Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 880.6512

FDA 专业组

General Hospital

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 ultraviolet light-based microbial reduction device for luer-activated valves is a device that uses ultraviolet light to irradiate luer-activated valves (e.g., as used for intravascular administration). The device is intended to supplement the manual, physical microbicidal treatment of luer-activated valves by providing limited microbial reduction, and is not intended to disinfect or replace manual microbicidal treatment.

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）。

该代码近三年的 510(k)（1 件）

数据窗口为最近三年。最新一件：2025-12-23。