EXT PROCESSING UNIT ACCESSORIE


Product Overview

EXT PROCESSING UNIT ACCESSORIE
VISITAG SURPOINT EPU - M660202SP


Device Description

A dedicated computer with software that is a component of a cardiac mapping system and is used to process and store electronic information/data for the interpretation of cardiac physiological parameters received from the output of connected measuring devices [e.g., body surface or intracardiac electrocardiograph (ECG) sensors/transducers]. The measurements can be compared to pre-established diagnostic criteria for parameters such as cardiac blood flow, electrical conduction, or heart chamber geometry. The device may display real-time cardiac maps in various formats (e.g., electrical propagation maps, electrical potential maps, and cardiac chamber geometry maps).


Environmental Conditions

  • Special Storage Condition, Specify
    • Keep Dry
  • Special Storage Condition, Specify
    • Do not use if package is opened
  • Special Storage Condition, Specify
    • Keep out of direct sunlight
  • Special Storage Condition, Specify
    • Do not use if package is damaged

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: OAD

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

    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 flutter.

    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 flutter.

    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: 10846835018554

    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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