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    K Number
    K241169
    Device Name
    Entarik NI Feeding Tube System
    Manufacturer
    Gravitas Medical, Inc.
    Date Cleared
    2024-11-22

    (210 days)

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

    Gravitas Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Entarik NI Feeding Tubes (FTs) are intended for the administration, fluids and medications by the nasoenteric or orogastric route for neonatal patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition. The Entarik NI Feeding Tube System (Entarik NI System) is designed to aid, in conjunction with institutional protocols, qualified operators in the placement of the Entarik NI Feeding Tube (FT) into the stomach of neonatal patients requiring enteral feeding. The Entarik FTs are equipped with sensors designed to provide information about the tube tip relative to the stomach, thus assisting in reducing the incidence of misplacement during first positioning. The Entarik NI FTs are provided sterile. The Entarik NI System also monitors the feeding tube position continuously during the course of feeding and automatically and in real time alerts of tube migration. The Entarik NI System provides continuous monitoring of gastric and esophageal temperature. The Entarik device can be used solely for the purpose of monitoring gastric and esophageal temperature in situations where invasive monitoring is indicated. The Entarik NI system is intended to record, store, view and analyze impedance in the pharynx and stomach.
    Device Description
    The Entarik NI Feeding Tube System (Entarik NI System) consists of the Entarik NI Feeding Tube (disposable) and the Entarik NI Monitor (reusable) with Power Supply. The Entarik NI System is designed for enteral feeding and to aid in the placement of the Entarik NI Enteral Feeding Tube into the stomach of neonatal patients requiring enteral feeding. The Entarik NI System also continuously monitors feeding tube position, gastric and esophageal temperature, and gastrointestinal impedance and reflux. The feeding tubes are single use devices intended for prolonged use (less than 30 days). The Entarik NI Feeding Tubes are provided sterile.
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    K Number
    K230206
    Device Name
    Entarik Feeding Tube System; Entarik Feeding Tube
    Manufacturer
    Gravitas Medical, Inc.
    Date Cleared
    2023-03-24

    (58 days)

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

    Gravitas Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Entarik Feeding Tube is intended for the administration of nutrition, fluids and medications by the nasoenteric route for patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition. The Entarik Feeding Tube System is designed to aid, in conjunction with institutional protocols, qualified operators in the placement of the Entarik Feeding Tube (Entarik FT) into the stomach of patients requiring enteral feeding, The Entarik FT is equipped with sensors designed to provide information about the tube tip relative to the stomach, thus assisting in reducing the incidence of misplacement during first positioning. The Entarik Monitors the feeding tube position continuously during the course of feeding and in real-time alerts of tube migration.
    Device Description
    The Entarik Feeding Tube System (Entarik System) consists of the Enteral Feeding Tube and the Entarik Monitor. The Entarik Feeding Tube is a nasogastric feeding tube with a single lumen for the administration of nutrition, fluids and medications. The Entarik Feeding Tube includes impedance and temperature sensors embedded within the tube, with wires located in the wall of the feeding tube. The Entarik Monitor is a portable electronic device that serves to measure and record impedance and temperature data from the sensors on the Feeding Tube and provides information to the operator to aid in initial placement and monitoring of feeding tube position.
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