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510(k) Data Aggregation

    K Number
    K131249
    Device Name
    ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
    Manufacturer
    I-FLOW LLC
    Date Cleared
    2014-02-03

    (278 days)

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

    I-FLOW LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The I-Flow Elastomeric Pump is intended for infusion of medications including antibiotic delivery, chemotherapy and pain management. Routes of administration include intravenous, subcutaneous and epidural. The I-Flow Elastomeric Pump is also intended for infusion of medication (such as local anesthetics or narcotics) for local or regional anesthesia and pain management. Routes of administration include: perineural (nerve block), into intraoperative sites (infiltration), percutaneous and epidural. The I-Flow Elastomeric Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to or around surgical wound sites or close proximity to nerves when compared with narcotic-only pain management. The indications for use include hospital, alternate care, ambulatory and home environments.
    Device Description
    The I-Flow Silicone/Non-DEHP Elastomeric Pumps consist of an elastomeric pressure source with an integrated administration set. The elastomeric membrane functions as the fluid reservoir and the pressure source. The desired flow rate is regulated by a restrictor orifice or fixed flow tubing that controls flow generated by the pressurized bladder. The pre-attached administration set may incorporate any of the following components: • Y-tubing for multi-site delivery (single or dual) • Air and particulate eliminating filter • Flow Restrictor • Luer Connector The pump may be sold as a kit with additional devices or accessories such as the following: catheter, introducer needle, syringe, and E-clip.
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