Catheter Introducer Kit


Product Overview

Catheter Introducer Kit
Chemosite - 120089


Device Description

A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.


Environmental Conditions

  • Handling Environment Temperature - Degrees Fahrenheit
    • 130.00
    • N/A

  • Device Sizes

  • Outer Diameter: .038 Millimeter
  • Needle Gauge,18,Gauge;
  • Total Volume: 12 Milliliter
  • Catheter Gauge: 7 French
    • Outer Diameter: .038 Millimeter
    • Needle Gauge,18,Gauge;
    • Total Volume: 12 Milliliter
    • Catheter Gauge: 7 French


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LJS

    Device Name: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: HO

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: N/A

    Regulation Number: 880.5970

    Third Party Flag: N

    Medical Specialty: HO


    Device Identifiers

    Device Id: 10884521099289

    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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