Electrode Headset

GUDID 00852745007079

BRAINSCOPE COMPANY, INC.

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• Primary Device ID: 00852745007079
• NIH Device Record Key: 354417d4-8530-41e7-a25b-00d1caf52ca9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Electrode Headset
• Version Model Number: 99-1403-202
• Company DUNS: 805670416
• Company Name: BRAINSCOPE COMPANY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com
• Phone: 240-752-7680
• Email: sabyasachi.roy@brainscope.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852745007062 [Primary]
GS1	00852745007079 [Package]; Contains: 00852745007062; Package: [25 Units]; In Commercial Distribution
GS1	00852745007147 [Package]; Contains: 00852745007062; Package: [25 Units]; In Commercial Distribution
GS1	00852745007154 [Package]; Contains: 00852745007062; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161068

FDA Product Code

• OLU: Normalizing Quantitative Electroencephalograph Software

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: 2018-10-25
• Device Publish Date: 2018-09-24

Devices Manufactured by BRAINSCOPE COMPANY, INC.

• 00852745007260 - Baseline Headset: 2021-11-23 A variant of the electrode headset that is to be used for Baseline sessions.
• 00852745007239 - BrainScope One: 2021-02-24 BrainScope Part Number 99-1801-100 (SKU: BSO-2001) Contains Device Identifier (DI) 00852745007222 - this is the DI for the Brain
• 00852745007109 - Ahead 300 International Charging Kit: 2020-02-06
• 00852745007130 - BrainScope One International Charging Kit: 2020-02-06
• 00852745007024 - Ahead 300: 2018-10-25
• 00852745007048 - Ahead Electrode Headset: 2018-10-25
• 00852745007079 - Electrode Headset: 2018-10-25
• 00852745007079 - Electrode Headset: 2018-10-25
• 00852745007123 - BrainScope One: 2018-10-25