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510(k) Data Aggregation

    K Number
    K030348
    Device Name
    BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE
    Manufacturer
    BIOLAB EQUIPMENT CANADA LTD.
    Date Cleared
    2003-10-21

    (260 days)

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

    BIOLAB EQUIPMENT CANADA LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to remove organic and inorganic substances and microbial contaminants from water that is used to dilute dialysis concentrate to form dialysate, and to produce purified water for dialyzer reprocessing, and equipment rinse and disinfection.
    Device Description
    The Biopure Series RO systems purify feed water through reverse osmosis a membrane separation process. In reverse osmosis, pressure is applied to force water through a semipermeable membrane, while leaving impurities on the feed side of the membrane. The membrane allows the solvent (water) to pass through but retains a large percentage of impurities such as dissolved inorganics, organics, bacteria, and pyrogens. The water that passes through the membrane (permeate), has significantly less contamination than the feed water. while the reject stream, which remains upstream of the membrane, has a much higher concentration than the feed stream. The purpose of a pretreatment to reverse osmosis is to remove chlorinel chloramines and condition the feed water supplying the RO machine. The pretreatment section may include feed water boost pumps, a temperature blend valve, chemical feed unit, sediment/carbon cartridge filters, water softeners, multi media filters, carbon filters and dealkalizers. The RO unit removes more than 99% of all micro-organisms, pyrogens, particles, and organics with a molecular weight greater than 300, and up to 95% of all dissolved inorganics. The elements of an RO unit include a prefilter, RO pressure pump, and RO membranes. The purpose of a product water distribution system is to deliver water that meets or exceeds AAMI/ASAIO standards for water treatment equipment and water quality requirements for hemodialysis point of use. Additional product water treatment is intended to control or eliminate bacteria prior to point of use. The product water treatment system may include a storage tank, distribution pump, a distribution loop, UV disinfection, and hot water sanitization. Depending on the series and model, Biopure water purification systems produce from 300 GPD (gallons per day) to 100 GPM (gallons per minute) at 75% recovery rate. Rejection of total dissolved solids and monovalent ions is in the range of 95%-99% depending on feed water characteristics. Colloids, bacteria, and organics larger than a 200 molecular weight are rejected at greater than 99%. Biopure water purification systems product water that meets the requirements of ANSI / AAMI RD5-1992, Hemodialysis Systems.
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