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510(k) Data Aggregation

    K Number
    K993272
    Device Name
    PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM
    Manufacturer
    PURE WATER, INC.
    Date Cleared
    2000-04-10

    (193 days)

    Product Code
    FIN
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    PURE WATER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pure Water, Inc.'s Bicarb Mix, Storage and Distribution system is intended to be used in the mixing, storage and distribution of Bicarb liquid concentrate to be used in the treatment of Hemodialysis patients.
    Device Description
    Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System uses Reverse Osmosis, provides for batch mixing of Bicarb liquid concentrate, transfer to storage and delivery to point of use. The Bicarb Mix Tank allows Bicarb liquid concentrate to be mixed in batches then transferred to a Storage Tank. The Storage and Distribution components of the system serve to deliver Bicarb liquid concentrate to the point of use. Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System can be customized to best meet the needs of the user. Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System meets or exceeds all Association for the Advancement of Medial Instrumentation (AAMI) National Standards for Hemodialysis.
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    K Number
    K992786
    Device Name
    PURE WATER, INC.'S WATER PURIFICATION SYSTEMS
    Manufacturer
    PURE WATER, INC.
    Date Cleared
    2000-01-24

    (158 days)

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

    PURE WATER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pure Water, Inc. Water Purification System is intended to be used in the purification of water to be used to dilute dialysate concentrate and in the reprocessing of dialyzers for reuse.
    Device Description
    The Pure Water, Inc. Water Purification System uses Reverse Osmosis technology to produce pure water. Reverse Osmosis utilizes a semi-permeable membrane and high hydrostatic pressure. Pretreatment is used for the purpose of removing elements present in the source water that can damage the RO membranes. The storage and distribution components of the system serves to deliver pure water produced by the RO to the point of use. The Pure Water, Inc. Water Purification System can be customized to best meet the water needs of the user.
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    K Number
    K993058
    Device Name
    PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL
    Manufacturer
    PURE WATER, INC.
    Date Cleared
    2000-01-24

    (133 days)

    Product Code
    FIN
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    PURE WATER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pure Water, Inc. Acidified Storage and Distribution system with Remote Fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of hemodialysis patients.
    Device Description
    Pure Water, Inc.'s Acidified Storage and Distribution System with Optional Remote Fill uses "one-piece molded seamless tanks constructed of linear polyethylene" for bulk storage of acidified concentrate. The Optional Remote Fill allows the storage tanks to be filled by the vendor from outside the building. Pure Water, Inc.'s Acidified Storage and Distribution System with optional Remote Fill meets or exceeds all Association for the Advancement of Medical Instrumentation (AAMI) National Standards for Hemodialysis.
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