Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Coude Urethral Catheter Kit


Product Overview

Bard® Touchless® Plus Unisex Pre
Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Coude Urethral Catheter Kit - 4A7116


Device Description

A sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Catheter Gauge: 16 French
    • Catheter Gauge: 16 French


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: FCM

    Device Name: Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

    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: 10801741046466

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00801741046469

    Package Quantity: 50

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CA


    Device Id: 00801741046469

    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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