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510(k) Data Aggregation

    K Number
    K061409
    Device Name
    SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET
    Manufacturer
    PRECISE MEDICAL PRODUCTS, LTD.
    Date Cleared
    2006-06-16

    (25 days)

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

    PRECISE MEDICAL PRODUCTS, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The modified SmartInfuser PainPump is intended to provide continuous delivery of a local anesthetic through a catheter inserted directly into the surgical site for postoperative pain management.
    Device Description
    The device comprises of the following parts: - SmartCatheter (optional) - - SmartInfuser set with SmartReg flow regulator, T Check Valve and Multi -Bolus (regulating set) - Compression unit (pump) - - 500 ml infusion bag (empty) - - Peel-off introducer(optional) - - Wound Dressing (Medical adhesive bandage) - - 50/60cc luer lock syringe - - -Medication label - Pump label - Instructions for use - Carrying pouch
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    K Number
    K042122
    Device Name
    SMARTINFUSER PAINPUMP
    Manufacturer
    PRECISE MEDICAL PRODUCTS
    Date Cleared
    2004-09-22

    (47 days)

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

    PRECISE MEDICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SmartInfuser PainPump™ is intended to provide continuous delivery of a local anesthetic through a catheter inserted directly into the surgical site for postoperative pain management.
    Device Description
    The device comprises of the following parts: - SmartCatheter - - SmartInfuser set with SmartReg flow regulator (regulating set) - - Compression unit (pump) - - 100 ml or 250 ml infusion bag (empty) - - Peel-off introducer - - -Medication label - Pump label - - Carrying pouch made of synthetic cloth - The empty infusion bag is included as a back-up container. Under normal circumstances, a standard solution bag filled by a pharmacist according to the physician's prescription will be used.
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