Norav Medical

Basic Information

• Brand Name: Norav Medical
• Primary DI: 04260498565948
• Version / Model: C3-C-U-LL-ODUR
• Catalog Number: C3-C-U-LL-ODUR
• Company Name: Norav Medical GmbH
• Labeler DUNS: 341318999
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-05
• Public Version: 2
• Public Version Date: 2020-04-06
• Public Version Status: Update
• Public Device Record Key: b5fea838-ebc1-4629-ba90-a916e42fdb89

Device Description

ECG Input Cable with 10kOhm Resistors and dedicated ODU Plug with AHA color coding to 3 Leads with Clip connectors

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: Yes
• 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: 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
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	04260498565948	GS1

Customer Contacts

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