CATHETER 307F3 FREEZOR3 MED BLUE 7F


Product Overview

CATHETER 307F3 FREEZOR3 MED BLUE 7F
Freezor® - 307F3


Device Description

A sterile, flexible device intended to be used as part of a cardiac tissue cryosurgical system to cryogenically ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and deliver pressurized liquid refrigerant (e.g., nitrous oxide) to its distal cooling segment to achieve extremely low temperatures through gas expansion; it typically includes sensors (e.g., temperature monitoring). 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
  • Storage Environment Temperature - Degrees Fahrenheit
    • 86.00
    • 59.00

  • Device Sizes

  • Curve length 53 mm
  • Tip length 4 mm
  • Shaft size 7 Fr
  • Length: 108.0 Centimeter
    • Curve length 53 mm
    • Tip length 4 mm
    • Shaft size 7 Fr
    • Length: 108.0 Centimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LPB

    Device Name: Cardiac Ablation Percutaneous Catheter

    Device Class: 3

    Physical State: N/A

    Definition: This product code pertains to cardiac ablation catheters indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product code excludes ablation catheters indicated for treatment of atrial flutter [product code oad] and atrial fibrillation [product code oae].

    Submission Type ID: 2

    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: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 00643169450400

    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


    GMDN ®. © GMDN Agency 2005-2024.
    Educational Resources
    Videos