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510(k) Data Aggregation

    K Number
    K191844
    Device Name
    Fidmi Low Profile Enteral Feeding Device
    Manufacturer
    Fidmi Medical Ltd
    Date Cleared
    2019-09-30

    (83 days)

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

    Fidmi Medical Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fidmi Low Profile Enteral Feeding Device is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means. Fidmi Low Profile Enteral Feeding Device Measuring kit is indicated for measuring the length of the stoma prior to placement of a low-profile feeding tube. The Fidmi Low Profile Enteral Feeding Device Replaceable Tube is intended for use only with the Fidmi Low Profile Enteral Feeding Device, for the replacement of an existing tube. It is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means.
    Device Description
    The Fidmi Low Profile Enteral Feeding Device and its components kits allow for enteral nutrition and / or medication delivery directly into the stomach. The device and components are supplied sterile. Fidmi Medical's Low-Profile Enteral Feeding Device includes kits for initial placement of the tube, and complete removal of the gastrostomy tubes. Fidmi Low-Profile Enteral Feeding Device incorporates three major components: The Stoma Measuring Device – The Fidmi Medical Stoma Measuring Device is a single use, sterile, disposable device designed for use in the selection of an appropriate length of the Feeding Device to be used exclusively with the Fidmi Low-Profile Enteral Feeding Device. Low Profile Enteral Feeding Device - The Low Profile Enteral Feeding Device consists of a gastric port that on one side (on the skin surface) includes the flexible external bumper that stabilizes the stoma and keeps the site dry and allows ventilation. On the other side (the stomach side), it includes the bumper that is designed to stay in place and to be dismantled apart for removal when enteral feeding is no longer required. The Replacement Feeding Tube – The replaceable tubing is designed to be easily replaced when needed. The replacement tube is designed as an internal component that may be retracted, disposed and replaced without any manipulation to the device itself, i.e., the gastrostomy tube implant. It is designed to be replaced by personnel at a medical facility or at a home setting. As depicted in the instructions for use document supplied with the device, it is recommended to replace the tube either upon accidental dislodgement, clogging or once a week.
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