AE-120A EEG Head Set NE-090S1

GUDID 14931921903053

Disposable Electrode for EEG

NIHON KOHDEN CORPORATION

Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use

• Primary Device ID: 14931921903053
• NIH Device Record Key: 83077d96-db78-4323-a301-7bae001e6902
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AE-120A EEG Head Set
• Version Model Number: NE-090S1
• Catalog Number: NE-090S1
• Company DUNS: 690568050
• Company Name: NIHON KOHDEN CORPORATION
• Device Count: 6
• 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)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: NeurologyTechSupport@nihonkohden.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04931921903056 [Unit of Use]
GS1	14931921903053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183529

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2019-06-14
• Device Publish Date: 2019-06-06

On-Brand Devices [AE-120A EEG Head Set]

• 14931921903053: Disposable Electrode for EEG
• 14931921903046: Disposable Electrode for EEG
• 04931921129975: EEG Head Set
• 04931921903582: AE-120A Accessory Kit with belts and forehead pad
• 04931921903278: Disk electrode for EEG