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510(k) Data Aggregation

    K Number
    K081264
    Device Name
    STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002
    Manufacturer
    CHILDREN'S HEALTH FIRST, INC.
    Date Cleared
    2009-02-13

    (284 days)

    Product Code
    FMQ, FPL
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHILDREN'S HEALTH FIRST, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Securing newborn infants of various sizes and weights within a Neonatal Transport Incubator.
    Device Description
    The STATStrap™ Neonatal Incubator Safety Strap is a soft closed cell foam material covered with a laminate of soft fabric that allows Hook (Velcro® style) fabric to attach to it along the straps entire length. The end of each strap incorporates a hook fabric wing tab or a wire spring hook, so as to attach each strap to the infant incubator tray. These 13 inch straps are positioned in four positions altation our carp to the menthess tray so as to fit the patient's size. Once the straps are in place and securely fastened to the mattress tray, the straps cross over the neonate ( infant's ) body in a "X" pattern and attach to each other so as to provide positioning aid, prevent gross body movement or falls of the patient. A hook "tie strap" is included on both models to secure the two main straps together into a single unit. These straps are single patient use disposable items. Labeling states the disposable nature of the strap, precautions and the use instructions.
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