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    K Number
    K161304
    Device Name
    EndoPur Filter
    Manufacturer
    Nephros Inc.
    Date Cleared
    2017-03-02

    (296 days)

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

    Nephros Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EndoPur Endotoxin 10" Filter Flat is intended to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
    Device Description
    The EndoPur Endotoxin 10" Filter Flat is a hollow fiber ultrafilter that retains bacteria, viruses, endotoxin and particulate from water used in hemodialysis.
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    K Number
    K161467
    Device Name
    HydraGuard 10 UltraFilter
    Manufacturer
    NEPHROS INC.
    Date Cleared
    2016-12-22

    (209 days)

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

    NEPHROS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HydraGuard 10" UltraFilter is intended to be used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filter aids in infection control. The filter produces water that is suitable for patient wound cleaning of equipment used in medical procedures and washing of surgeon's hands. Medical: The filter is not intended to provide water that can be used as a substitute for USP sterile water.
    Device Description
    Not Found
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