Product code SGX

Device name

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

Medical specialty

General Hospital

Device class

2

Regulation number

880.6512

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset