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

Product Code

SGX

Device Class

FDA class 2

Regulation Number

880.6512

Medical Specialty

General Hospital

Review Panel

HO

Submission Type

1

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.

This FDA classification is associated with 1 510(k) clearance via K numbers.

This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.