SGX

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

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

Device class

Class II (moderate risk)

Regulation

21 CFR 880.6512

Medical specialty

General Hospital

FDA definition

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.

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