Norav 1200 Series PC-ECG

Basic Information

• Brand Name: Norav 1200 Series PC-ECG
• Primary DI: 04260498566877
• Version / Model: 1200HR Kit
• Catalog Number: 1200HR-K-00-E-S10-04
• Company Name: Norav Medical GmbH
• Labeler DUNS: 341318999
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-09
• Public Version: 1
• Public Version Date: 2020-07-17
• Public Version Status: New
• Public Device Record Key: 5fc28a80-6d70-467a-8b58-7c378a76068b

Device Description

Kit includes: PC-ECG 1200HR (UDI: 04260498566822) for High Resolution Resting-ECG and Stress-Test ECG recordings with IEC type labelling. Input cable with 10 Patient leads IEC type and Snap connectors.

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	04260498566877	GS1

Customer Contacts

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