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    K Number
    K993024
    Device Name
    CELSITE IMPLANTABLE PORT WITH VALVED CATHETER
    Manufacturer
    B. BRAUN OF AMERICA, INC.
    Date Cleared
    2000-03-13

    (186 days)

    Product Code
    LJT
    Regulation Number
    880.5965
    Why did this record match?
    Applicant Name (Manufacturer) :

    B. BRAUN OF AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Over a long period of time Used intravenously for chemotherapy, anti-biotics; anti-viral drugs, and for parenteral nutrition. They are also used for blood transfusions or blood sampling in small quantities.
    Device Description
    The Celsite® Implantable Port with Valved Catheter is composed of materials that have been tested in accordance with the ISO Standard 10993-1 and have been determined to be suitable for the intended use of this product.
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    K Number
    K983794
    Device Name
    CHEMO MINI SPIKE PLUS
    Manufacturer
    B. BRAUN OF AMERICA, INC.
    Date Cleared
    1999-03-23

    (147 days)

    Product Code
    LHI
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    B. BRAUN OF AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IV additive dispensing pin for aspiration from multi-dose containers or injection into IV systems
    Device Description
    The Chemo Mini Spike Plus is an IV additive dispensing pin for aspiration from multidose containers or injection into IV systems (IV bag).
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