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510(k) Data Aggregation

    K Number
    K033208
    Device Name
    IVY DEVICES INC. IV/MEDICAL LINE STABILIZER
    Manufacturer
    Date Cleared
    2004-03-18

    (168 days)

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

    IVY DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IV/Medical Line Stabilizer is non-sterile, single use, identified in 21 CFR 880.5440, as a medical device intended to be used by personnel who are most often in contact with pediatric patients that have intravenous lines or medical lines attached to them. The IV/Medical Line Stabilizer is made of latex-free food grade transparent plastic. The primary purpose of this device is to reduce the risk of intravenous and other medical line entanglement. The design of the IV Stabilizer helps prevent IV wraps or medical line(s) from entangling around itself and around the patient.
    Device Description
    The IV/Medical Line Stabilizer is non-sterile, single use, identified in 21 CFR 880.5440, as a medical device intended to be used by personnel who are most often in contact with pediatric patients that have intravenous lines or medical lines attached to them. The IV/Medical Line Stabilizer is made of latex-free food grade transparent plastic. The primary purpose of this device is to reduce the risk of intravenous and other medical line entanglement. The design of the IV Stabilizer helps prevent IV wraps or medical line(s) from entangling around itself and around the patient.
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