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510(k) Data Aggregation

    K Number
    K141200
    Device Name
    PADI-LOCK
    Manufacturer
    Date Cleared
    2014-10-02

    (146 days)

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

    PADI-LOCK, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For use with a vascular access device for the administration of drugs and solutions. The Padi-Lock Medical Tubing Length Reducing Apparatus can be connected to the administration set by snaking through the device to shorten the length of the tubing. The device is intended to be used in hospitals and home patient care worere IV tubing is used.
    Device Description
    The Padi-Lock was designed to control the excess length in IV tubing. This patented device efficiently reduces the slack in tubing that can get tangled or tripped on causing additional patient injury or discomfort. The Padi-Lock hangs freely on the IV tubing. The Padi-lock efficiently reduces up to 32 inches of excess IV tubing. The Padi-Lock is made of polystyrene. The device dimensions are 7.5'' x 4.42'' x 0.28" (L x W x H) with a tube channel designed to fit the outer dimension of IV tubing (0.14"). The tubing is snaked through the device so that it securely sits in the channel for unobstructed flow of the fluid through the tubing.
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