NikoClips

Basic Information

• Brand Name: NikoClips
• Primary DI: 10853512006629
• Version / Model: NIK-20W
• Catalog Number: NIK-20W
• Company Name: NIKOMED USA
• Labeler DUNS: 073648341
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-04-03
• Public Version: 2
• Public Version Date: 2020-07-02
• Public Version Status: Update
• Public Device Record Key: 01972ad3-bf71-4cdb-8944-fe76ebf4f80b

Device Description

Adapter clips for ECG diagnostic and monitoring electrodes

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: 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
DRX	Electrode, Electrocardiograph	Cardiovascular	870.2360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60635	Electrocardiographic electrode connector	A small clip designed to enable an electrical connection between an electrocardiographic electrode and an electrocardiographic lead wire. It is typically made of plastic materials, with a metallic part to provide electrical connection, and can be manually applied to a dedicated area of a disk-like electrode that is placed on the patient’s skin, with a socket at the other end for a plug on the lead. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10853512006629	GS1
Unit of Use	00853512006622	GS1