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510(k) Data Aggregation

    K Number
    K060333
    Device Name
    DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM
    Manufacturer
    DIALYSIS SERVICES, INC.
    Date Cleared
    2006-09-08

    (211 days)

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

    DIALYSIS SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The bicarbonate mixing and distribution system and its components consisting of; tanks, pumps, piping, and controls, are designed to consistently, safely, and effectively mix and distribute bicarbonate solutions for hemodialysis treatments. NOTE: Federal Law restricts this device to sale by or on the order of a physician for use as a bicarbonate mixing and distribution system for hemodialysis.
    Device Description
    Device is designed to provide the user with a system for consistent and easy to use system by which they may be able to mix and distribute bicarbonate solution for use in a hemodialysis clinic.
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    K Number
    K043344
    Device Name
    DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM
    Manufacturer
    DIALYSIS SERVICES, INC.
    Date Cleared
    2005-03-23

    (107 days)

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

    DIALYSIS SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The water treatment system and its components consisting of; pretreatment, reverse osmosis machine, and the product water distribution components, are designed to remove microbiological, organic, and inorganic contaminants from the tap water to supply dialysis machines for the preparation of dialysate solutions for hemodialysis treatments. NOTE: Federal Law restricts this device to sale by or on the order of a physician for use as a water treatment device for hemodialysis.
    Device Description
    The water treatment system and its components consisting of; pre-treatment, reverse osmosis machine, and the product water distribution components, are designed to remove microbiological, organic, and inorganic contaminants from the tap water to supply dialysis machines for the preparation of dialysate solutions for hemodialysis treatments. Pretreatment components can include a tap water boosting system, blending valve, sediment filtration, carbon removal system, blomaing vars, and all the necessary interconnecting nlumbing. The purpose of this part of the system is to ensure that properly conditioned water is supplied to the reverse osmosis machine to ensure its safe and trouble free operation. The blending valve ensures that the water is at the proper temperature when entering the reverse osmosis machine. The tap water booster system helps ensure that the reverse osmosis machine has adequate water pressure and volume so it can produce the desired amount of water. The sediment filters can be in the form of an automatic backwashing filter (such as a multi-media depth filter), or as a replaceable filter cartridge. The carbon filters are installed primarily to remove the amount of chlorine and chloramines from the water to meet the necessary water quality standards and can be in the form of automatic backwashing tanks, or portable exchange tanks. The water softener(s) are in place to remove the hardness from the tap water to both meet water quality standards, and to protect the reverse osmosis membranes from scaling and therefore not performing to specifications. After the tap water has been pre-treated, it then enters the R.O. (reverse osmosis), where total dissolved solids are removed to pertinent water quality standards. This is accomplished by utilizing a membrane separation process, whereby the incoming water is separated into a product stream, and a concentrate stream. The molecular weight cut-off determines what and how many contaminants are passed through into the product stream. R.O.s used for this application typically remove 95-99% of all total dissolved solids and bacteria. The product water distribution part of the system is in place to store, provide additional purification if needed, and deliver the purified water to wherever needed. These components can include such things as a storage tank, deionization tanks, final filters (for bacteria and endotoxins), and delivery pumps and controls. Some systems can also utilize an ultraviolet light for additional sterilization properties. The distribution piping encompasses the piping and related fittings to deliver the dialysis water from the water treatment system to the use points (dialysis machines) and return the unused portion of water back to the water treatment system.
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