FIRMap Catheter 60mm, PACKAGED - Abbott (Global)

Product Overview

FIRMap Catheter 60mm, PACKAGED
FIRMap - AR064060

Device Description

A sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device.

Environmental Conditions

  • Special Storage Condition, Specify
    • Keep Dry
  • Storage Environment Atmospheric Pressure - KiloPascal
    • 106000.00
    • 50000.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 100.00
    • 10.00
  • Storage Environment Temperature - Degrees Celsius
    • 25.00
    • 2.00

  • Device Sizes

  • Circumference: 60 Millimeter
    • Circumference: 60 Millimeter

    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    Code: MTD

    Device Name: Catheter, Intracardiac Mapping, High-Density Array

    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: 870.1220

    Third Party Flag: N

    Medical Specialty: CV

    Device Identifiers

    Device Id: 00810591020024

    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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