Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K083583
    Device Name
    XPRESSE INJECTION SYSTEM
    Manufacturer
    NORDSON EFD
    Date Cleared
    2009-06-30

    (208 days)

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

    NORDSON EFD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XPRESSE Assist Device is a syringe assist device intended for use in the administration of sterile materials under aseptic conditions in accordance with the best judgment of the clinician.
    Device Description
    The XPRESSE Assist Device is a non-sterile, air/gas-powered device that is used to assist the clinician in dispensing the contents of a prefilled piston syringe into the body. The clinician connects the XPRESSE Assist Device to the desired syringe, and uses the foot pedal to activate the XPRESSE Assist Device. When activated by the foot pedal, the XPRESSE Assist Device allows flow of compressed air/gas, which pushes the syringe plunger forward, dispensing the syringe contents. The XPRESSE Assist Device is compatible with standard glass or plastic barrel syringes. The XPRESSE Assist Device includes the following components: - a controller to provide regulated, compressed air/gas to a syringe (syringe not a part of this device), - a foot switch connecting to the control unit for clinician activation of the system, and - a disposable adaptor and tubing unit, with integral plastic tube connecting the controller to the desired syringe. The controller includes an electrically-powered LED display to indicate system pressure settings and to allow activation/inactivation of the foot pedal. Pressure is adjustable by the clinician from 0 to 100 psi using the controller knob located on the front face plate of the controller. The XPRESSE Assist Device is compatible with either a compressed air canister (45-gram CO2) or facility compressed air.
    Ask a Question

    Page 1 of 1