NIKOPrep 2121/E 240

GUDID 00853512006776

Strips for Skin Preparation (Individual Pieces)

NIKOMED USA

Electrode skin abrasion pad Electrode skin abrasion pad Electrode skin abrasion pad Electrode skin abrasion pad Electrode skin abrasion pad Electrode skin abrasion pad Electrode skin abrasion pad Electrode skin abrasion pad Electrode skin abrasion pad Electrode skin abrasion pad Electrode skin abrasion pad Electrode skin abrasion pad Electrode skin abrasion pad Electrode skin abrasion pad Electrode skin abrasion pad

• Primary Device ID: 00853512006776
• NIH Device Record Key: c3a4fd37-722c-4375-a4d3-b7cb3b6fab04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIKOPrep
• Version Model Number: 2121/E 240
• Catalog Number: 2121/E 240
• Company DUNS: 073648341
• Company Name: NIKOMED USA
• Device Count: 500
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853512006776 [Unit of Use]
GS1	10853512006773 [Primary]

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: 2022-10-27
• Device Publish Date: 2022-10-19

On-Brand Devices [NIKOPrep]

• 00853512006776: Strips for Skin Preparation (Individual Pieces)
• 00853512006769: Strips for Skin Preparation (1 card of 5 pieces)