ECGenius System CVT-0069 R3.2 ECGenius System

GUDID 05745001034009

The ECGenius™ System is an electrophysiology measurement system and analysis tool used to acquire, filter, digitize, amplify, display, record, and analyze data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party stimulator, intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart. The PVI Analyzer™ feature is a secondary measure of pulmonary vein isolation and should not replace traditional methods of confirming isolation.

Cathvision ApS

Cardiac electrophysiology analysis system

• Primary Device ID: 05745001034009
• NIH Device Record Key: e1124c88-39c5-4b38-984f-f4c384204c5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECGenius System
• Version Model Number: CVT-0069 R3.2
• Catalog Number: CVT-0069 R3.2 ECGenius System
• Company DUNS: 305415202
• Company Name: Cathvision ApS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05745001034009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223787

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-30
• Device Publish Date: 2024-04-22

On-Brand Devices [ECGenius System]

• 05700002168528: The ECGenius System is a computerized electrophysiology measurement system designed for both re
• 05700002168535: The ECGenius™ System is an electrophysiology measurement system and analysis tool used to acqu
• 05745001034009: The ECGenius™ System is an electrophysiology measurement system and analysis tool used to acqu