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Title
Preconfigured Hemodialysis Systems- NxStage System One with Pureflow SL
Memo #
16-32-ESRD
Posting Date
2016-07-29
Fiscal Year
2016
Summary
• The NxStage System One with PureFlow SL is a preconfigured hemodialysis system that is Food and Drug Administration (FDA) approved to meet the Association for the Advancement of Medical Instrumentation (AAMI) standards for water quality and dialysate. • Preconfigured hemodialysis systems differ from traditional hemodialysis water systems and therefore all the requirements of 42 CFR 494.40 Water and Dialysate Quality will not be applicable to the function of a preconfigured hemodialysis system. • Consistent with 42 CFR 494.40 (e) surveyors must evaluate water and dialysate quality for preconfigured hemodialysis machines by ensuring that the FDA and manufacturer’s labeling for the machine are followed by the facility.
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