Lubri-Sil® I.C. Complete Care® All-Silicone Foley Catheter Tray and Urine Meter


Product Overview

Lubri
Lubri-Sil® I.C. Complete Care® All-Silicone Foley Catheter Tray and Urine Meter - 307416A


Device Description

A collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). 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: EZL

    Device Name: Catheter, Retention Type, Balloon

    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: 10801741019767

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00801741019760

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CA


    Device Id: 00801741019760

    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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