Bardex® Lubricath® Temperature-Sensing Foley Catheter


Product Overview

Bardex® Lubricath® Temperature
Bardex® Lubricath® Temperature-Sensing Foley Catheter - 117416


Device Description

A sterile, flexible tube with an inflatable balloon on its distal tip for retention in the urinary bladder, after its insertion through the urethra, where it functions as a long-term indwelling device for continuous urinary drainage and simultaneous monitoring of core body temperature through its integral temperature sensor, typically during or after surgery or in the presence of obstruction or paralysis. It may have a bent tip (coude) for negotiation of the prostatic curve and is typically made of silicone. It is inserted by trained staff and commonly known as a Foley catheter. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Catheter Gauge: 16 French
  • Length: 5.3 Millimeter
    • Catheter Gauge: 16 French
    • Length: 5.3 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: EZC

    Device Name: Catheter, Coude

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: GU

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 876.5130

    Third Party Flag: Y

    Medical Specialty: GU


    Device Identifiers

    Device Id: 10801741076937

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00801741076930

    Package Quantity: 6

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CA


    Device Id: 00801741076930

    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


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