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510(k) Data Aggregation

    K Number
    K960512
    Device Name
    GEMINI PC-ITX
    Manufacturer
    IMED CORP.
    Date Cleared
    1996-11-21

    (290 days)

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

    IMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gemini family infusion devices are intended for intravascular administration of fluids, of medications, blood, and blood products into a patient in a controlled manner.
    Device Description
    The IMED GEMINI PC-1TX Volumetric Infusion Pump/Controller is a single channel linear peristaltic infusion device. PC-1TX incorporates the same general safety features exhibited in the Models PC-1, PC-2, PC-2TX, and PC-4. The PC-1TX has been designed as a fail-safe device which utilizes state-of-the-art microprocessor circuitry to monitor the operation of the device and to alarm visually and/or audibly whenever assigned parameters have been exceeded, resulting in shutdown until corrective actions, as indicated, have been completed by the user. The PC-1TX displays information relative to operations including advisories, prompts, alarms, and malfunctions.
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    K Number
    K953896
    Device Name
    THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS
    Manufacturer
    IMED CORP.
    Date Cleared
    1996-03-20

    (216 days)

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

    IMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMED Ambulatory Infusion System is intended for use in a health care facility as well as home health care setting to pump standard IV fluids, medications, blood and blood products into a patient in a controlled manner.
    Device Description
    The IMED Ambulatory Infusion System is comprised of a cassette assembly and the pump. The system uses a rotary peristaltic pumping action which physically pumps fluid to the patient when used in conjunction with the dedicated administration sets. Various confiqurations of the IV administration sets are available. The IMED Ambulatory Infusion System incorporate the following features: - Battery status Indicator; provides estimated remaining battery run time. - Ease of Use; provides operator queries, visual and audio alarms. - Flow Rates; range of 0.1-999 mL/hr - Free Flow Protection; administration set-based protection. - Occlusion Pressure; provides multiple detection options. - Secondary Infusion; provides dual rate sequential piggyback infusions. - Tamper-resistant Mode; provides the ability to lockout kevpad. - Volume-To Be-Infused; range of 0.1-9999 mL.
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