Product Overview

Portex - 101/506/035


Device Description

A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • 3.5mm
  • Circumference: 4 Millimeter
    • 3.5mm
    • Circumference: 4 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: JOH

    Device Name: Tube Tracheostomy And Tube Cuff

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: AN

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: Y

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 868.5800

    Third Party Flag: Y

    Medical Specialty: AN


    Device Identifiers

    Device Id: 35019517046193

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 15019517046199

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: BOX


    Device Id: 15019517046199

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


    Device Id: 55019517046197

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 35019517046193

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CARTON


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