RediTube™ Tracheal Tube Oral/Nasal with Preloaded Stylet


Product Overview

RediTube™ Tracheal Tube Oral/Nasal with Preloaded Stylet
RediTube™ - 8080RTC


Device Description

A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated; it does not include an antimicrobial agent(s). The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 49.00
    • N/A

  • Device Sizes

  • Lumen/Inner Diameter: 8.0 Millimeter
  • Outer Diameter: 10.9 Millimeter
  • Cuff Resting Diameter: 26±15% Millimeters
    • Lumen/Inner Diameter: 8.0 Millimeter
    • Outer Diameter: 10.9 Millimeter
    • Cuff Resting Diameter: 26±15% Millimeters


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: BTR

    Device Name: Tube, Tracheal (W/Wo Connector)

    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: 868.5730

    Third Party Flag: N

    Medical Specialty: AN


    Device Identifiers

    Device Id: 50885403296084

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 20885403296083

    Package Quantity: 4

    Package Discontinue Date: 3/31/2022 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: CS


    Device Id: 10885403296086

    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: 70885403296088

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10885403296086

    Package Quantity: 20

    Package Discontinue Date: 3/31/2022 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: PAK


    Device Id: 20885403296083

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 70885403296088

    Package Quantity: 2

    Package Discontinue Date: 3/31/2022 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: BOX


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