HEARTRAIL III Guiding Catheter


Product Overview

HEARTRAIL III Guiding Catheter
HEARTRAIL - 40-5344


Device Description

A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.


Environmental Conditions

  • Special Storage Condition, Specify
    • Fragile. Keep dry. Keep away from sunlight. Stacking limit by 10.

  • Device Sizes

  • Length: 100 Centimeter
  • Lumen/Inner Diameter: 1.47 Millimeter
  • Outer Diameter: 1.75 Millimeter
  • Shape name of distal shaft is JR3.5
  • Pressure: 4826 KiloPascal
    • Length: 100 Centimeter
    • Lumen/Inner Diameter: 1.47 Millimeter
    • Outer Diameter: 1.75 Millimeter
    • Shape name of distal shaft is JR3.5
    • Pressure: 4826 KiloPascal


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DQO

    Device Name: Catheter, Intravascular, Diagnostic

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: CV

    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: 870.1200

    Third Party Flag: Y

    Medical Specialty: CV


    Device Identifiers

    Device Id: 54987350866276

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 04987350866271

    Package Quantity: 5

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Carton


    Device Id: 04987350866271

    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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