- Physicians Office Resource

TRUPULSE Generator
TRUPULSE™ Generator - D141702

Device Description

A cardiac-dedicated mains electricity (AC-powered) device designed to generate microsecond electrical pulses to produce irreversible cell membrane electroporation (a phenomenon that induces cell membrane pores to open resulting in loss of homeostasis and subsequent cell death) for the selective nonthermal ablation of cardiac tissues. It includes controls (e.g., foot-switch), user interface, and is designed to connect to appropriate cardiac mapping equipment and catheter (not included).

Environmental Conditions

Special Storage Condition, Specify

Keep Dry

Special Storage Condition, Specify

Do not stack

Special Storage Condition, Specify

Keep away from sunlight

Storage Environment Atmospheric Pressure - millibar

1060.00
500.00

Storage Environment Humidity - Percent (%) Relative Humidity

85.00
10.00

Storage Environment Temperature - Degrees Celsius

60.00
-40.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: QZI

Device Name: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

Device Class: 3

Physical State: The device is an ablation catheter that features electrodes through which pulsed electric fields are 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: N

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: 10846835025248

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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