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510(k) Data Aggregation

    K Number
    K052817
    Device Name
    EUREKA INFUSION PUMP, MODELS EUREKA-IP, EUREKA-LF
    Date Cleared
    2006-04-17

    (195 days)

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

    UNIVERSAL MEDICAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Infusions Of volumes between 50 mL to 100 ml. Via Intravenous catheter or central IV line or subcutaneous route In Ambulatory , Home or Hospital Setting For General Use
    Device Description
    The Eureka Infusion Pump and predicate devices functions with the use of restriction tubing. Pressure is exerted on a IV solution containers. When the air is pumped in to the bladder enlarges. The pressure against the IV solution container forces the IV solution to flow through the administration set. The Eureka Infusion Pump is designed to house a pre-filled IV solution container. The housing consists of Polycarbonate material for srtength. The administration sets are a PVC tubing set and attached spike of ABS plastic. Performance characteristics also include the ability of sensors to determine pressure being exerted on the bag and the logic control to regulate this pressure by powering on and off the air pump, and venting pressure through a relief valve. Each Eureka Pump Model is supplied with the following optional component/accessories Pump, Recharger/Power Supply, Battery Pack, Carry Pack, Manual The Eureka-IP and Eureka-LF Infusion Pumps are reusable.
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