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510(k) Data Aggregation

    K Number
    K042089
    Device Name
    NX STAGE WATER PURIFICATION SYSTEM
    Date Cleared
    2004-11-24

    (113 days)

    Product Code
    Regulation Number
    876.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    NX STAGE MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NxStage Water Purification System is a stand-alone water treatment system designed to pretreat and purify water for use in hemodialysis applications. The purified water can be used in preparation of dialysate, equipment rinsing and disinfection, and dialyzer reprocessing. It is intended to be used in a variety of environments, including acute or chronic care facility or home.
    Device Description
    The NxStage Water Purification System is a stand-alone water System designed to pre-treat and purify water for use with hemodialysis applications. The purified water can be used in preparation of dialysate, equipment rinsing and disinfection, and dialyzer reprocessing. The System is intended to be used in a variety of environments, including an acute or chronic care facility or the home. There are no known contraindications with the use of the NxStage Water Purification System. The System is single patient use and is comprised of three major components: 1) a pretreatment system which consists of a check valve, sediment filter and air vent to remove trapped air, sediment, and any impurities, 2) a Pump Controller unit which contains the control and safety software that controls the flow rate, monitors pressure, water quality and system operation and 3) a replaceable resin system that removes organic and inorganic chemical contaminants as well as microbiological contaminants such as bacteria and endotoxins. The System flow rate is specified by the end user. With proper use, the System will produce water that meets or exceeds the requirements of the standard issued by the American National Standard Institute and the Association for the Advancement of Medical Instrumentation: ANSI/AAMI RD62:2001, Water Treatment Equipment for Hemodialysis Applications.
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