TRACE 1 0916

GUDID 00853512006653

ECG Electrodes

NIKOMED USA

Electrocardiographic electrode, single-use

• Primary Device ID: 00853512006653
• NIH Device Record Key: 5ef770f6-6cd1-4643-ae00-88ed5d1e9f61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRACE 1
• Version Model Number: 0916
• Catalog Number: 0916
• Company DUNS: 073648341
• Company Name: NIKOMED USA
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853512006653 [Unit of Use]
GS1	10853512006650 [Primary]
GS1	20853512006657 [Package]; Contains: 10853512006650; Package: Bx [10 Units]; In Commercial Distribution
GS1	30853512006654 [Package]; Contains: 20853512006657; Package: Cs [6 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: 2020-02-24
• Device Publish Date: 2020-02-14

On-Brand Devices [TRACE 1]

• 30853512006487: ECG Electrodes
• 00853512006653: ECG Electrodes
• 00853512006806: ECG Electrodes