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510(k) Data Aggregation

    K Number
    K120272
    Device Name
    AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET
    Manufacturer
    KENTEC MEDICAL, INC.
    Date Cleared
    2012-02-17

    (18 days)

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

    KENTEC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Enteral Feeding Extension Set (EFES) is intended for use as an extension set for nasogastric/ oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental misconnection with an I.V. system to the enteral system or the enteral system to an I.V. system.
    Device Description
    The Kentec Medical Enteral Feeding Extension Set (EFES) is a sterile disposable device for single patient use only. The device is designed to connect existing feeding tubes (nasogastric, oralgastric, gastric, etc) to various delivery enteral syringes as well as to help minimize the potential for inadvertent delivery of enteral feedings through the intravenous route. i.e., the device cannot be connected to a luer connector. The device consist of flexible PVC tubing with an orange strip for easy quick identification of enteral feeding lines as well as a "For Enteral Feeding Only" tag and a slide clamp to provide the additional safety assurance for connection errors. The basic set (OC-ENT-60) consists of tubing with a step connector (catheter tip) and an oral syringe connector not compatible with intravencus (I.V.) tubing or stopcocks. Other variations include: - The basic set with shorter tubing (OC-ENT-36) t - The basic set with step connector changed into oral syringe connector . (20C-ENT-60) - The basic set with the addition of a "Y" site with an oral syringe connector . to allow the clinician to attach other equipment.
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    K Number
    K100526
    Device Name
    AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE
    Manufacturer
    KENTEC MEDICAL, INC.
    Date Cleared
    2010-04-22

    (57 days)

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

    KENTEC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Amertius Entral™ Feeding Tube is intended for nasogastric delivery of various types of liquid nutritional media through the gastro intestinal tract of neonatal and small pediatric patients, and is not intended for use beyond 30 days.
    Device Description
    The Ameritus Entral™ Feeding Tubes are composed of two families of Feeding Tubes each made with different materials: polyurethane and silicone. The two families of Feeding Tubes are all made with a single lumen catheter that is used to deliver fluids as prescribed by the physician including liquid nutritional media and/or medication. The Ameritus Entral " Feeding Tubes are sterile, individually packaged, Latex Free and DEHP Free. The orange color coding provides easy visual recognition of the enteral connection. The Ameritus Entral "" Feeding Tubes are designed with a Radiopaque stripe for X-ray visualization to confirm proper feeding tube placement. French size and length clearly printed on the feeding tube as well as centimeter markings (approx.) to assist tube placement or check for migration. A Tethered plug for connector closure is incorporated to prevent air and fluid ingress when not in use. The device consists of the following main components: A feeding tube single lumen catheter and a connector with molded closure plug.
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    K Number
    K050443
    Device Name
    ACCU-LEAD
    Manufacturer
    KENTEC MEDICAL, INC.
    Date Cleared
    2005-09-02

    (192 days)

    Product Code
    DRX
    Regulation Number
    870.2360
    Why did this record match?
    Applicant Name (Manufacturer) :

    KENTEC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Single Use Only - Disposable The NEONATAL PEDIATRIC ECG ELECRODE is intended for use whenever cardiac monitoring of neonatal or pediatric patients is deemed or desirable by trained medical or emergency personnel. This electrode is for use on the surface of the body,
    Device Description
    NEONATAL PEDIATRIC ECG ELECTRODE
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    K Number
    K970686
    Device Name
    ACCUTEMP-PROBE
    Manufacturer
    KENTEC MEDICAL, INC.
    Date Cleared
    1997-08-25

    (181 days)

    Product Code
    FMT
    Regulation Number
    880.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    KENTEC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    There are two modes of operation for temperature control in incubators and infant warmers where these products are used, air or manual mode and baby or skin temperature control mode. When operating in the air or manual mode, a skin temperature probe may be used just to monitor the patient's skin temperature. Here, a nurse would control the heater output manually. When operating in the "Baby" or "Skin Temperature Control Mode" the warming units controller utilizes the skin temperature probe, connected between the controller and the infant, to automatically adjust the heater output of the unit to maintain a pre-selected skin temperature.
    Device Description
    There are two modes of operation for temperature control in incubators and infant warmers where these products are used, air or manual mode and baby or skin temperature control mode. When operating in the air or manual mode, the skin temperature probe may be used just to monitor the patient's skin temperature. Here, a nurse would control the heater output manually. When operating in the "Baby" or "Skin Temperature Control Mode" the warming units controller utilizes the skin temperature to automatically adjust the heater output of the unit to maintain a pre-selected skin temperature. The thermistor tip which gets taped to the infant is made of a material whose resistance to electrical flow changes when the tip materials temperature changes. Two small wires run from the plug end at the incubator or warmer to the thermistor tip. One wire to each side. A very small current goes to the tip and depending on how warm the tip is has to do with how much current returns via the other wire to the plug. That current is computed into temperatures. These products fit the Steinhart-Hart equation which is the standard for describing thermistor curves.
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    K Number
    K960080
    Device Name
    ACCUTEMP PROBE
    Manufacturer
    KENTEC MEDICAL, INC.
    Date Cleared
    1996-05-01

    (111 days)

    Product Code
    FMT
    Regulation Number
    880.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    KENTEC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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