Elefix V Paste for EEG & EMG ZV-401E

GUDID 04931921005767

Elefix Electrode Adhesive, 400g tubs

NIHON KOHDEN CORPORATION

Electrode conductive medium

• Primary Device ID: 04931921005767
• NIH Device Record Key: 14ba44eb-3810-4ac6-be32-206d3a7df126
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elefix V Paste for EEG & EMG
• Version Model Number: ZV-401E
• Catalog Number: ZV-401E
• Company DUNS: 690568050
• Company Name: NIHON KOHDEN CORPORATION
• Device Count: 1
• 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: false
• 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)325-0283
• Email: info@nkusa.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04931921005767 [Package]; Contains: 04931921005835; Package: Box [3 Units]; In Commercial Distribution
GS1	04931921005835 [Primary]

FDA Product Code

• GYB: MEDIA, ELECTROCONDUCTIVE

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: 2020-04-01
• Device Publish Date: 2020-03-24

On-Brand Devices [Elefix V Paste for EEG & EMG]

• 04931921005781: Elefix Electrode Adhesive, 180g tubes
• 04931921005767: Elefix Electrode Adhesive, 400g tubs