High Resolution 12 lead ECG

Basic Information

• Brand Name: High Resolution 12 lead ECG
• Primary DI: 07290110252892
• Version / Model: PCECG 1200HR
• Catalog Number: 1200HR-D-00U-01
• Company Name: NORAV MEDICAL LTD.
• Labeler DUNS: 514773159
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-26
• Public Version: 7
• Public Version Date: 2019-09-27
• Public Version Status: Update
• Public Device Record Key: c10f0944-376a-487e-9c8c-7cf0568af880

Device Description

PC-ECG Acquisition Device for Resting-ECG and Stress-Test ECG applications with AHA labelling. The very high signal resolution allows the device to be used for scientific diagnostics (e.g. Late Potential or HRV).

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
MWI	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36719	Electrocardiographic signal amplifier	An electrical device that amplifies the signal level and provides impedance matching between two or more medical devices when bioelectrical signals from the heart are transmitted between them.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290110252892	GS1
Package	07290110252878	GS1	Carton Box	1	In Commercial Distribution

Customer Contacts

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