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    K Number
    K124024
    Device Name
    APD LUER-LOCK ADAPTER
    Manufacturer
    FRESENSIUS MEDICAL CARE NORTH AMERICA
    Date Cleared
    2013-09-19

    (265 days)

    Product Code
    KDJ
    Regulation Number
    876.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    FRESENSIUS MEDICAL CARE NORTH AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fresenius APD Luer-Lock Adapter is intended for use with an Automated Peritoneal Dialysis cycler for the exchange of peritoneal dialysis solution. The single-use device is designed to connect any Fresenius cycler set with a Safe-Lock® connector to a peritoneal dialysis solution bag equipped with a standard luer-lock connector.
    Device Description
    The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock® connector (e.g., Liberty® cycler, Newton IQ® cycler).
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