EME EME3015-5S

GUDID 20853512006947

ECG Electrodes

NIKOMED USA

Electrocardiographic electrode, single-use

• Primary Device ID: 20853512006947
• NIH Device Record Key: 72a13389-eb2b-4d7a-87cd-0cb011dd9e2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EME
• Version Model Number: EME3015-5S
• Catalog Number: EME3015-5S
• Company DUNS: 073648341
• Company Name: NIKOMED USA
• Device Count: 60
• DM Exempt: false
• Pre-market Exempt: true
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853512006943 [Unit of Use]
GS1	10853512006940 [Primary]
GS1	20853512006947 [Package]; Contains: 10853512006940; Package: Bx [20 Units]; In Commercial Distribution
GS1	30853512006944 [Package]; 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: 2025-11-19
• Device Publish Date: 2025-11-11

Devices Manufactured by NIKOMED USA

• 00853512006974 - NIKO: 2025-12-17 THERMAL RELECTORS - LARGE
• 00853512006981 - NIKO: 2025-12-17 THERMAL REFLECTORS - SMALL
• 20853512006947 - EME: 2025-11-19ECG Electrodes
• 20853512006947 - EME: 2025-11-19 ECG Electrodes
• 20853512006954 - NIKOTRACE: 2025-08-18 ECG Electrodes
• 20853512006961 - NIKOTRACE: 2025-08-18 Repositionable ECG Electrodes
• 30853512006517 - NikoSurg: 2025-06-18 Neutral Electrodes
• 20853512006572 - NikoSurg: 2025-06-18 Neutral Electrodes
• 20853512006817 - NIKOTRACE: 2025-03-31 ECG Electrodes