CARDIO MONITOR CENTER VISION

Basic Information

• Brand Name: CARDIO MONITOR CENTER VISION
• Primary DI: 07290008960427
• Version / Model: S-CV8-00
• Company Name: SHL TELEMEDICINE INTERNATIONAL LTD.
• Labeler DUNS: 531817906
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-22
• Public Version: 1
• Public Version Date: 2023-08-30
• Public Version Status: New
• Public Device Record Key: 0fdfd5c1-a692-4b0b-942a-547d910847b6

Device Description

The Cardio Monitor Center Vision™ is a stand-alone medical device software operating on the physical or virtual personal computer in the organizational network and designed to work in combination with the medical device (remote personal ECG transmitter) to receive medical data (digital ECG data as an input) converting it to the interpretable ECG graph (software output). The Cardio Monitor Centre Vision displays 12 ECG leads ECG and Rhythm strip. The software received the data via proxy server and converts it to the graph of voltage versus time, displaying the heart's electrical forces, as viewed from 12 different electrical perspectives (points of view) - 12 leads, created by electrodes touching the skin.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DPS	Electrocardiograph	Cardiovascular	870.2340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44098	Cardiology information system application software	An application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of cardiology services and facilities. It is typically supplied for installation into a dedicated information system for cardiology or existing mainframe or decentralized computers/networks.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290008960427	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]