KIT 20MRK ARCTIC FRNT MANETRACT GLB ROHS


Product Overview

KIT 20MRK ARCTIC FRNT MANETRACT GLB ROHS
N/A - 20MRK


Device Description

A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.


Environmental Conditions

  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 85.00
    • N/A
  • Handling Environment Temperature - Degrees Fahrenheit
    • 136.00
    • -31.00
  • Special Storage Condition, Specify
    • Keep Dry
  • Storage Environment Temperature - Degrees Fahrenheit
    • 86.00
    • 59.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: OAE

    Device Name: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

    Device Class: 3

    Physical State: The device is an ablation catheter that features electrodes through which thermal energy is delivered.

    Definition: For the treatment of atrial fibrillation.

    Submission Type ID: 2

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: The ablation catheter delivers energy to the specific region of the heart in order to create lesions that will treat the patient of atrial fibrillation.

    Life Sustain Support Flag: Y

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Heart

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 00763000279783

    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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