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    K Number
    K993806
    Device Name
    DIALGUARD ENDOTOXIN REMOVAL DEVICE
    Manufacturer
    CLARIGEN, INC.
    Date Cleared
    2000-08-14

    (279 days)

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

    CLARIGEN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DialGuard™ device is intended to be used for the reduction of endotoxin from: 1. Dialysate prior to entering the dialyser 2. Water prior to its use for preparation of dialysate 3. Water prior to use for regenerating dialysers. DialGuard™ is intended to be used on a regular preventative basis during hemodialysis treatments. Experimental data indicates that DialGuard TM will consistently reduce endotoxin levels to ≤ 0.05 EU/mL. (AAMI standard for water for dialysate is < 5.0 EU/mL. Currently, there are no standards set for dialysate).
    Device Description
    DialGuard™ is a device used for the reduction of endotoxin from dialysate and water. It consists of a polysulfone housing filled with an affinity resin with polysulfone endcaps. The endcaps are fitted with Quick Connect couplings.
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