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510(k) Data Aggregation

    K Number
    K123282
    Device Name
    DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS
    Date Cleared
    2013-04-25

    (185 days)

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

    **ULTRAPURE **& INDUSTRIAL SERVICES LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ultrapure & Industrial Services (UIS) Deionization Tanks are exchangeable/rechargeable mix bed tanks intended to remove ions from the water to a sufficient level to allow safe treatment of Hemodialysis patients. These deionization tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pre-treatment and post treatment. Upon, exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or new resin altogether. The Ultrapure & Industrial Services Carbon Exchange Tanks are activated carbon tanks intended to remove chlorine and chloramines from the water to allow safe treatment of Hemodialysis patients. These carbon tanks are not be used alone, but are intended to be part of a larger water treatment system employing adequate pretreatment and post-treatment. Upon exhaustion, these tanks will be replaced with other tanks containing new activated carbon. All Ultrapure & Industrial Services Deionizer and Carbon Exchange Tank Service for hemodialysis are intended to be used in a hemodialysis facility according to ANSI/AAMI-RD62:2006 standards to supply purified water for use in hemodialysis.
    Device Description
    Deionizers: Ultrapure & Industrial Services Mixed Bed Deionization Exchange Tanks (DI) are Fiberglass Reinforced Polypropylene (FRP) tanks filled with mixed bed deionization resin. The tank sizes are common for the Dialysis industry with similar inlet and outlet fittings, PVC or Noryl heads and tank distributors. The DI Exchange Tanks are dedicated for ion exchange resin only. Our tanks are designed to deliver Association for the Advancement of Medical Instrumentation (AAMI) standard water through an ion exchange process to remove contaminantes from water being fed to the system. The DI system exchanges hydrogen ion (H+) for cations and hydroxyl ions (OH-) for anions in the feed water. The hydrogen and hydroxyl ions then combine to form pure water (H2O). The tanks are based on the AmeriWater Dialysis Deionizer Exchange Tanks K991519. Similar to predicate AmeriWater, Ultra-Pure segregated aseptic exchange deionizer service in an on-line worker/polisher arrangement with a temperature compensated 1 megobm/cm resistance light monitor with audible alarm between the worker/polisher and a 0-19 megohm/cm temperatura compensated digital readout resistance meter with adjustable remote audio and visual alarm. Upon exhaustion, these tanks are replaced with other Deionization Tanks containing newly regenerated resin or with new resin altogether. Carbon: Ultrapure & Industrial Services Carbon Exchange Tanks are Fiberglass Reinforced Polypropylene (FRP) tanks filled with new activated carbon. This carbón filtration, often referred to as granular activated carbón (GAC), will remove chlorine and chloramine that are almost always present in the source water through a chemical process knows as "adsorption". The tank sizes are common for the Dialysis industry with similar inlet and outlet fittings; PVC or Noryl heads and tank distributors. The Carbon Exchange Tanks are dedicated for carbon only. Ultrapure & Industrial Services always recommends that two tanks be installed in series, with the first tank providing the primary purification and the second tank serving as backup. Same recommendation is offered by the predicate. The tanks are based on the AmeriWater Dialysis Carbon Exchange Tanks K991519. Dialysis segregated exchange process carbon service utilizes new virgin coal based granular activated carbon (GAC) of 12X40 mesh size with an iodine number of 1000 or greater. The tanks are disinfected with chlorine and cleaned before delivery to the dialysis application. Batch codes and dates are used to insure quality and freshness of the tanks. The tanks are re-bedded under our FDA/OS system with batch control of capacity, quality and microbiological control. Ultrapure & Industrial Services process includes a use of medical-grade carbon only followed by a 24-hour soak to fully wet the carbon followed by complete back-washing to remove any contaminants and provide a more natural pH product.
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