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.