TRACE 1

Basic Information

• Brand Name: TRACE 1
• Primary DI: 10853512006650
• Version / Model: 0916
• Catalog Number: 0916
• Company Name: NIKOMED USA
• Labeler DUNS: 073648341
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2020-02-14
• Public Version: 1
• Public Version Date: 2020-02-24
• Public Version Status: New
• Public Device Record Key: 5ef770f6-6cd1-4643-ae00-88ed5d1e9f61

Device Description

ECG Electrodes

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
35035	Electrocardiographic electrode, single-use	A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00853512006653	GS1
Primary	10853512006650	GS1
Package	20853512006657	GS1	Bx	10	In Commercial Distribution
Package	30853512006654	GS1	Cs	6	In Commercial Distribution

Customer Contacts

• Phone: [phone] ext. 205
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 41 – 86 Degrees Fahrenheit