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510(k) Data Aggregation

    K Number
    K963440
    Device Name
    DIALOG DIALYSIS MACHINE
    Manufacturer
    B. BRAUN MEDICAL AG
    Date Cleared
    1998-06-26

    (665 days)

    Product Code
    KDI
    Regulation Number
    876.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    B. BRAUN MEDICAL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the device is for Volume controlled ultrafiltration and infusion of heparin through a blood pump for the treatment of renal failure or toxic Conditions. This device may be used for High. Flux Hemodialysis.
    Device Description
    The Dialog Dialysis Machine is an artificial kidney system used for the treatment of patients with renal failure or toxic conditions. The device consists of an extracorporeal blood system for the separation of substances in solutions via a semipermeable membrane. The system allows for volume controlled ultfiltration and/or infusion of heparin through a blood pump by utilizing a standard double needle or optional single needle dialysis procedure.
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    K Number
    K962084
    Device Name
    OMNICAN SYRINGE
    Manufacturer
    B. BRAUN MEDICAL AG
    Date Cleared
    1997-02-10

    (257 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    B. BRAUN MEDICAL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Omnican Syringe is designed to be used for subcutaneous, injection.
    Device Description
    The Omnican Syringe is composed of materials that have been tested in accordance with ISO 10993 for plastics and determined to be sultable for the intended use of this product. The syringes are packaged in boxes of 100 each. Each box contains a magnifier to assist in reading the scale on the syringe barrel.
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