TUBING SET CEDTTS100 5PK US


Product Overview

TUBING SET CEDTTS100 5PK US
DiamondTemp™ Irrigation Tubing Set - CEDTTS100


Device Description

A collection of sterile flexible tubing and associated items that may include clamps, filters, and connectors, used with an irrigation pump to deliver irrigation and/or cooling solution (saline) to an ablation device (e.g., an ablation catheter or a cardiac tissue ablation system applicator) at a specified flow rate during a cardiac electrophysiology (EP) ablation procedure. The tubing is made of synthetic material and is of a fixed diameter that is specific to the requirements of the pump. This is a single-use device.


Environmental Conditions

  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 90.00
    • 15.00
  • Handling Environment Temperature - Degrees Fahrenheit
    • 140.00
    • -22.00
  • 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: 20763000482163

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00763000482169

    Package Quantity: 5

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: PK


    Device Id: 00763000482169

    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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