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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ultraviolet light-based microbial reduction device for luer-activated valves
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.
Product CodeSGX
Regulation Number 880.6512
Device Class 2


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HAI SOLUTIONS
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