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510(k) Data Aggregation

    K Number
    K082182
    Device Name
    AP 34 MULTI-THERAPY INFUSION PUMP
    Manufacturer
    Q-CORE, LTD
    Date Cleared
    2008-08-15

    (14 days)

    Product Code
    FRN, FPA, MRZ
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    Q-CORE, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AP 34 is a multi-therapy infusion pump system designed for the volumetric infusion of medication and nutritional fluids to patients in the hospital, homecare and outpatient environments in the following delivery modes: CONTINUOUS; INTERMITTENT; PCA (Patient Control Analgesia) and TPN (Total Parenteral Nutrition). The AP 34 is not intended for the following use or substances: - Delivery of blood or cellular blood products . - . Intra-cardiac use. The AP 34 infusion pump includes the following accessories: - Bolus cable . - Q--Core approved AC/DC adaptor (external)] . - Cradle (optional) and power cable for cradle . - Rechargeable battery pack for pump . - . PCA cover box - Communication cables . The dedicated Q-Core Administration Sets for the AP 34 infusion pump are intended for single-patient use only. The AP 34 infusion pump system is for prescription use only.
    Device Description
    The Q-CORE AP 34 multi-therapy Infusion Pump is a software driven, volumetric, ambulatory infusion pump for the delivery of measured amounts of medication or parenteral nutrition at a controlled rate. The AP 34 uses Q-Core approved disposable Administration Sets, including the Q-Core designed Magic Straw™ cassette. The AP 34 operates by means of an electro-mechanical pumping mechanism based on Q-Core patented Electromagnetic Flow Control (EFC™) valve technology. The pumping mechanism is a single channel, with an integral pressure sensor and real time flow correction capacity; the pumping mechanism produces a peristaltic pumping action.
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