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    K Number
    K052764
    Device Name
    DIACAP ULTRA DIALYSIS FLUID FILTER
    Manufacturer
    B. BRAUN MEDIZINTECHNOLOGIE GMBH
    Date Cleared
    2006-06-09

    (252 days)

    Product Code
    FKQ, FKP
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FKQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diacap Ultra Dialysis Fluid Filter is intended to filter bacteria and endotoxins from dialysate used for hemodialysis treatments.
    Device Description
    The Diacap Ultra dialysis fluid filter is sterile, non-pyrogenic dialysis fluid filter for use with machines providing hemodialysis treatments. The device is composed of a hollow core polysulfone and polyvinylpyrrolidone membrane, polycarbonate housing and headers (end-caps) with Hansen type connectors, silicone O-rings, and polyethylene port caps.
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