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510(k) Data Aggregation

    K Number
    K043207
    Device Name
    OZONE GENERATOR
    Manufacturer
    GE INFRASTRUCTURE WATER & PROCESS TECHNOLOGIES
    Date Cleared
    2005-11-04

    (350 days)

    Product Code
    NII, FIN
    Regulation Number
    876.5860
    Why did this record match?
    Product Code :

    NII

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The O3Z Ozone System is an optional accessory for the Solution Delivery Systems (SDS) manufactured by GE Infrastructure, Water & Process Technologies and is intended to be used for disinfection of the SDS bicarb mixing and distribution system. The mix tank of the SDS system is filled with either RO or deionized water and the mix tank ozone concentration is increased to 0.70 mg/L. The solution is then distributed to the distribution tank of the SDS system. From the distribution tank, the ozonated water is distributed throughout the distribution loop of the SDS system until a minimum ozone concentration level of 0.30 mg/L is established at the end of the SDS bicarb distribution loop. The solution is then recirculated for a minimum of 15 minutes throughout the distribution system. To complete the disinfection process, the system is then rinsed with RO or deionized water until the system is residual free of ozone.
    Device Description
    The Ozone Generating System attaches to the Solution Delivery System (SDS) through a valve bypass system and an injector. It is wall mounted in the vicinity of the SDS and is connected to the injector, which is installed in the output piping of the mix pump. The SDS mix tank is filled with RO or DI water; the bypass valves are manually configured for ozone production and then the mix pump is started, causing the injector to draw O3/air mixture into solution. When the proper concentrations of ozone are achieved, the ozonated water is re-circulated throughout the mixing and delivery system to disinfect the fluid path.
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    K Number
    K023064
    Device Name
    HEMOCLEAN
    Manufacturer
    KRD CO., LTD
    Date Cleared
    2004-04-06

    (568 days)

    Product Code
    NII
    Regulation Number
    876.5860
    Why did this record match?
    Product Code :

    NII

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HEMOCLEAN® is intended for the disinfection of artificial kidney machines (hemodialysis machines). It should be used under the following the dilution rate and contact condition: | Hemodialysis Machine | Dilution rate | Contact time | |----------------------|---------------|--------------| | COBE CentrySystem 3 | 1:9 | 10 minutes. | | Nikkiso DBB 22B | 1:34 | 29 minutes. | | Fresenius 2008K. | 1:34 | 15 minutes. | | Gambro Phoenix | 1:25 | 15 minutes. |
    Device Description
    HEMOCLEAN® is a single component germicide that does not require mixing or activation. HEMOCLEAN® is a stabilized mixture of hydrogen peroxide 5.3%(<6.0%) and peracetic acid 1.7%; inert ingredients are 93%. The product is a clear colorless liquid, high acid, and completely soluble in water. HEMOCLEAN® finally breaks down to carbon dioxide, water, and oxygen. The product is used full strength with automated dilution by the hemodialysis machine for the intended use. It is packaged in five liters polyethylene containers with a vent filter on the cap and is shipped in two 5-liter containers per box. The shelf life of the concentrate is one year when properly stored. HEMOCLEAN® is indicated for the disinfection of hemodialysis machines. To use HEMOCLEAN® in automated hemodialysis machines, the user should follow the manufacture's recommendations for dilution of peracetic acid-based disinfectants. AAMI-quality water for hemodialysis must be used for diluting HEMOCLEAN® in the hemodialysis machine.
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