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510(k) Data Aggregation

    K Number
    K133334
    Device Name
    VERITRACT ENTERAL FEEDING TUBE SYSTEM
    Manufacturer
    Date Cleared
    2014-08-26

    (301 days)

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

    VERITRACT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Veritract Enteral Feeding Tube System is intended for use in those patients who require intermittent or continuous tube feeding via the nasogastric route. The vision and steering provided by the Veritract System is intended as an adjunct to current practices to aid qualified clinicians with experience in placing naso-enteric feeding tubes into the stomach or small bowel of patients requiring enteral feeding. Placement of the tip of the device into the small bowel should only be attempted by clinicians with expertise in small bowel placement. Confirmation of correct tube placement by X-ray or acceptable hospital protocol is required prior to commencing administration. The Veritract Enteral Feeding Tube has not been tested for use longer than shortterm use (<30 days).
    Device Description
    Not Found
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