OMNITRACE

Basic Information

• Brand Name: OMNITRACE
• Primary DI: 10653405001072
• Version / Model: 3600-005
• Catalog Number: 3600-005
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 600
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2023-02-24
• Public Version Status: Update
• Public Device Record Key: 69db9804-cb8b-44fd-9133-b92a382518d0
• Distribution End Date: 2023-02-24

Device Description

OMNITRACE FOAM, ADULT ECG ELECTRODE

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
Package	20653405001079	GS1		600	Not in Commercial Distribution	2023-02-24
Primary	10653405001072	GS1
Unit of Use	00653405001075	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K091856	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -20 – 55 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 41 – 95 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 5 – 35 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 41 – 95 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -4 – 131 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: High: 85 Percent (%) Relative Humidity