Bardex® I.C. 30cc/ml Balloon Foley Catheter


Product Overview

Bardex® I.C. 30cc/ml Balloon Foley Catheter
Bardex® I.C. Foley Catheter - 0167SI26


Device Description

A flexible tube with an inflatable balloon on its distal tip intended to be inserted through the urethra and retained in the urinary bladder of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage. It is used for a variety of conditions causing urinary retention (e.g., postoperative, obstruction). Commonly known as a Foley catheter, it is inserted by trained staff and may have a bent tip (coude) to facilitate insertion. It is also coated with an antibiotic or antimicrobial agent to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Catheter Gauge: 26 French
    • Catheter Gauge: 26 French


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: MJC

    Device Name: Catheter, Urological (Antimicrobial) And Accessories

    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: 10801741017336

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00801741017339

    Package Quantity: 12

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CA


    Device Id: 00801741017339

    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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