Bardex® Pedatric All-Silicone Foley Catheter 3cc Balloon

Product Overview

Bardex® Pedatric All
Bardex® Pediatric All-Silicone Foley Catheter - 165808

Device Description

A flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage; it might also be designed for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

  • Catheter Gauge: 8 French
    • Catheter Gauge: 8 French

    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    Code: KOD

    Device Name: Catheter, Urological

    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: 10801741029711

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00801741029714

    Package Quantity: 12

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CA

    Device Id: 00801741029714

    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

    Educational Resources