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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, water purification, general medical use
Regulation Description Water purification system for hemodialysis.
Definition The device is a portable water treatment system which features components and technology similar to water treatment systems previously cleared for hemodialysis. The difference lies with the intended use, as the proposed device is not intended for use in hemodialysis applications, for which a product code currently exists. Instead, the proposed device is intended for use to purify water for general purposes, including washing of surgeons hands, surgical instruments, and wound cleansing.
Product CodeNHV
Regulation Number 876.5665
Device Class 2