Nikotab 1015

GUDID 00853512006752

ECG Electrodes

NIKOMED USA

Electrocardiographic electrode, single-use

• Primary Device ID: 00853512006752
• NIH Device Record Key: 849bbccd-b399-41bb-9800-df54c29dfdf1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nikotab
• Version Model Number: 1015
• Catalog Number: 1015
• Company DUNS: 073648341
• Company Name: NIKOMED USA
• Device Count: 100
• 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
• 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
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853512006752 [Unit of Use]
GS1	10853512006759 [Primary]
GS1	20853512006756 [Package]; Contains: 10853512006759; Package: Bx [5 Units]; In Commercial Distribution
GS1	30853512006753 [Package]; Contains: 20853512006756; Package: Cs [10 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: 2022-09-14
• Device Publish Date: 2022-09-06

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• 00853512006776 - NIKOPrep: 2022-10-27 Strips for Skin Preparation (Individual Pieces)
• 00853512006752 - Nikotab: 2022-09-14ECG Electrodes
• 00853512006752 - Nikotab: 2022-09-14 ECG Electrodes
• 20853512006640 - NikoSurg: 2022-02-03 Neutral Electrodes
• 00853512006745 - Nikomed ECG Cable: 2021-01-29 3 Lead Monitor Cable