Norav 1200 Series PC-ECG

Basic Information

• Brand Name: Norav 1200 Series PC-ECG
• Primary DI: 04260498564057
• Version / Model: C10-C-E-D-10k-03
• Catalog Number: C10-C-E-D-10k-03
• Company Name: Norav Medical GmbH
• Labeler DUNS: 341318999
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-18
• Public Version: 1
• Public Version Date: 2023-02-27
• Public Version Status: New
• Public Device Record Key: 62e73e92-f156-47e7-8d4a-c408cd1450e7

Device Description

12 Lead ECG Cable with D15 type plug and Clip electrode connectors and build-in 10kOhm resistor

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
IKD	Cable, Electrode	Physical Medicine	890.1175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35562	Electrocardiographic lead set, reusable	A collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260498564057	GS1

Customer Contacts

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