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510(k) Data Aggregation

    K Number
    K051943
    Device Name
    SUREFLOW SAFETY INFUSION DEVICE
    Date Cleared
    2005-10-04

    (78 days)

    Product Code
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTRASAFE MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SureFlow™ Safety Infusion Device is a device intended to allow a health care practitioner to administer multiple intravenous medications simultaneously to a patient's vascular system utilizing needleless components and an I.V. manifold via syringe, gravity or infusion pump. By being needleless, it operates as a safety device which is designed to aid in reducing the possibility of accidental needle sticks.
    Device Description
    The SureFlow™ Safety Infusion Device is a needleless, sterile, non-pyrogenic single use intravenous fluid administration set which provides multiple access ports and regulates the directional flow of fluids for simultaneous intravenous therapy. It has 3 ports with swabable luers, integrated check valves, and pre-attached needleless injection ports all connecting to a drip chamber. A 4th port with a swabable luer and pre-attached needleless injection port allows for flushing of the chambers. It is manufactured with conventional medical grade, biocompatible materials. It operates as a safety device by eliminating the use of needles in the delivery of medications via IV infusion, thus eliminating the opportunity for accidental needlesticks. In addition, the SureFlow™ aids in reducing nosocomial infections by not requiring a break in the fluid path once the needleless syringes are connected to the SureFlow™. The valves are swabbed prior to connection which provides an uninterrupted, sterile fluid path versus the current practice of repetitive access to the IV port with needles which are exposed to airborne contamination. It is supplied sterile for single use only
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