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510(k) Data Aggregation

    K Number
    K060488
    Device Name
    DERMATECH IV HOLDER
    Date Cleared
    2006-06-08

    (104 days)

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

    DERMATECH MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DermaTech IV Holder is intended as an intravascular administration set to administer fluids through a catheter or needle inserted into a patients artery or vein.
    Device Description
    The DermaTech Sterile IV Holder is a sterile tape-less anchoring system comprising of Non-pyrogenic, PVC tubing with ABS male and female luer locks at each end, two Low Density Polyethylene Clam Shell tubing holders with a Polypropylene Hybrid Stretch Bonded Laminate Velcro strap. Once a needle or catheter is inserted into the artery or vein the DermaTech Sterile IV Holder is attached and provides a app-lecs a securing method to administer IV fluids.
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