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510(k) Data Aggregation

    K Number
    K030652
    Device Name
    MEDRO SPD
    Manufacturer
    U.S. FILTER/IONPURE, INC.
    Date Cleared
    2003-09-03

    (187 days)

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

    U.S. FILTER/IONPURE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The USFilter MedRO - SPD is a single/acute care patient reverse osmosis unit intended to supply water that is used for hemodialysis treatments. The water produced will meet the minimum water quality requirements as specified by ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications (RD5:1992 and RD62:2001) and the CSA Water Treatment Equipment and Water Quality Requirements for Hemodialysis (CSA-Z364.2.2-03) when used as directed. Dependent on feed water quality this unit may be used in conjunction with other approved water treatment components.
    Device Description
    MedRO™-SPD is a reverse osmosis unit used to purify water in hemodialysis applications.
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    K Number
    K013677
    Device Name
    MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM
    Manufacturer
    U.S. FILTER/IONPURE, INC.
    Date Cleared
    2002-03-08

    (121 days)

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

    U.S. FILTER/IONPURE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The USFilter/lonpure Med-RO™ Reverse Osmosis System is intended to supply water for use in the preparation of dialysate for hemodialysis patients and for other hemodialysis-related procedures such as cleaning, rinsing of equipment, and reprocessing of dialyzers. The water produced will meet the minimum water quality requirements as specified by ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications RD 62:2001[RD-5: 1992 if Treatment Equipment for Temodiarysle Applications RD & LES T.(RE ST 1000 in conjunction with other components of a water treatment system as necessary with compatible input and output water requirements.
    Device Description
    The Med-RO™ Reverse Osmosis System is a machine used to purify water.
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    K Number
    K980182
    Device Name
    WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
    Manufacturer
    U.S. FILTER/IONPURE, INC.
    Date Cleared
    1998-11-16

    (300 days)

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

    U.S. FILTER/IONPURE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The USFitter water punfication systems discussed in this premarket notification are intended for use in hemodialysis applications. The water purification systems are used to remove organic and inorganic substances and microbial contaminants from the subcent can be dilute dialysis concentrate to form water used to cince broyous began for other Gialysate, and rinse and disinfection.
    Device Description
    Water Purification System
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