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510(k) Data Aggregation

    K Number
    K213507
    Device Name
    AquaA
    Manufacturer
    Fresenius Medical Care Rental Therapies Group, LLC
    Date Cleared
    2022-07-27

    (268 days)

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

    Fresenius Medical Care Rental Therapies Group, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system, and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
    Device Description
    The AquaA system is a reverse osmosis (RO) water purification system that uses pretreated soft water to produce dialysis water for hemodialysis (HD) devices and for the preparation of dialysis concentrates. The AquaA system is a modular system consisting of a base module that can be used on its own or in conjunction with other modules. AquaA is the base module. AquaA2 is a second RO unit that can be added to increase the quality of dialysis water. AquaHT is a flow heater unit that can be added to provide heat disinfection for the RO system including membranes and ring main. The AquaHT module can also supply hot product water to connected HD devices. AquaUF is an ultrafiltration module for the AquaA system intended to improve dialysis water quality by retaining constituents such as endotoxins and bacteria.
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