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510(k) Data Aggregation

    K Number
    K082710
    Device Name
    SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SET
    Manufacturer
    NEOCHILD, LLC
    Date Cleared
    2009-01-23

    (129 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOCHILD, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infant Feeding tube is intended to be placed into the stomach to permit the introduction of fluids as directed by the physician Intended for nasogastric or orogastric placement Lumited to < 30 day placement Not intended for transpyloric placement
    Device Description
    The proposed modification to Infant Feeding Tube and accessories is to add additional materials that the feeding tube may be made from, 1 e , silicone and polyurethane In addition, we offer accessories an enteral extension set and syringe with non-IV connector These may be sold with the Feeding tubes or separately There is an option of the connectors being standard IV luer lock or a special non-IV connector which was cleared under K072756 The feeding tubes are a small diameter tube of various diameters, 4, 5, and 8 French, and various lengths They have an integral female fitting There are 2 eyelets near the tup of the tube They have markings along the shaft of the tubing and an integral radiopaque line They are provided sterile We will offer a non-sterile syringe with the appropriate mating, non-IV connector as part of the package, which was also cleared under K072756
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