NIKOTRACE 4039

GUDID 20853512006909

Repositionable ECG Electrodes

NIKOMED USA

Electrocardiographic electrode, single-use

• Primary Device ID: 20853512006909
• NIH Device Record Key: d528cff7-0228-4c30-b1d7-3de4956d6c73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIKOTRACE
• Version Model Number: 4039
• Catalog Number: 4039
• Company DUNS: 073648341
• Company Name: NIKOMED USA
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)355-6456
• Email: info@nikomedusa.com
• Phone: +1(800)355-6456
• Email: info@nikomedusa.com
• Phone: +1(800)355-6456
• Email: info@nikomedusa.com
• Phone: +1(800)355-6456
• Email: info@nikomedusa.com
• Phone: +1(800)355-6456
• Email: info@nikomedusa.com
• Phone: +1(800)355-6456
• Email: info@nikomedusa.com
• Phone: +1(800)355-6456
• Email: info@nikomedusa.com
• Phone: +1(800)355-6456
• Email: info@nikomedusa.com
• Phone: +1(800)355-6456
• Email: info@nikomedusa.com
• Phone: +1(800)355-6456
• Email: info@nikomedusa.com
• Phone: +1(800)355-6456
• Email: info@nikomedusa.com
• Phone: +1(800)355-6456
• Email: info@nikomedusa.com
• Phone: +1(800)355-6456
• Email: info@nikomedusa.com
• Phone: +1(800)355-6456
• Email: info@nikomedusa.com
• Phone: +1(800)355-6456
• Email: info@nikomedusa.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853512006905 [Unit of Use]
GS1	10853512006902 [Primary]
GS1	20853512006909 [Package]; Contains: 10853512006902; Package: Bx [200 Units]; In Commercial Distribution
GS1	30853512006906 [Package]; Package: Cs [12 Units]; In Commercial Distribution

FDA Product Code

• DRX: Electrode, electrocardiograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-31
• Device Publish Date: 2025-03-21

On-Brand Devices [NIKOTRACE]

• 20853512006923: ECG Electrodes
• 20853512006909: Repositionable ECG Electrodes
• 20853512006893: ECG Electrodes
• 20853512006886: ECG Electrodes
• 20853512006879: ECG Electrodes
• 20853512006862: ECG Electrodes
• 20853512006855: ECG Electrodes
• 20853512006848: ECG Electrodes
• 20853512006831: ECG Electrodes
• 00853512006820: ECG Electrodes
• 20853512006817: ECG Electrodes
• 20853512006961: Repositionable ECG Electrodes
• 20853512006954: ECG Electrodes