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510(k) Data Aggregation

    K Number
    K091386
    Device Name
    MICROFUSE DUAL RATE INFUSER
    Manufacturer
    NUMIA MEDICAL TECHNOLOGY, LLC
    Date Cleared
    2009-10-02

    (144 days)

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

    NUMIA MEDICAL TECHNOLOGY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroFuse Dual Rate infuser is intended to be used for the intermittent administration of I.V. medication.
    Device Description
    The Numia Medical Technology Dual Rate Infuser, or MicroFuse, is a battery powered, portable device that automates the injection of the contents of a syringe into a patient. The MicroFuse was originally developed and cleared through FDA by Baxa Corporation of Englewood Colorado under K983321. Each MicroFuse has two predetermined rates that are preset at the manufacturing facility. These preset rates cannot be modified by the user or patient. The MicroFuse is used in conjunction with a sterile administration set for injecting the medication into a syringe, the contents of meaned of the syringe at a controlled, pre-determined rate, delivering the dose in patient it depresses the praiger of the MicroFuse is offered in thee models a standard dual the synnge over an extended ported on extended infuse model. The only difference between these being the prodet, and infusion rates programmed into the device's software. The MicroFuse System consists of the MicroFuse Dual Rate Infuser and a syringe and administration I he Microruse and administration sets are sterile and disposable. Since only the accessory syringes and administration sets are in the fluid path, the MicroFuse has no patient contact materials. This also means the device is not provided sterile, nor is it sterilized in the field.
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