Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves
SGX · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.6512
Classification
FDA Product Code
SGX
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.6512
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.