BrainScope One BSO-3001

GUDID 00852745007284

This record is for BrainScope Part Number 99-1801-200 (SKU: BSO-3001) which is the BrainScope Ahead 500 CUBC1 Kit. Contains Device Identifier (DI) 00852745007277 - this is the DI for the BrainScope One (CUBC1) Device (BrainScope Part Number 50-1801-203)

Brainscope Company, Inc.

Electroencephalograph

• Primary Device ID: 00852745007284
• NIH Device Record Key: a2064658-6d00-433a-a259-37658c26f859
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BrainScope One
• Version Model Number: Ahead 500 CUBC1
• Catalog Number: BSO-3001
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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: 240-752-7680
• Email: quality@brainscope.com
• Phone: 240-752-7680
• Email: quality@brainscope.com
• Phone: 240-752-7680
• Email: quality@brainscope.com
• Phone: 240-752-7680
• Email: quality@brainscope.com
• Phone: 240-752-7680
• Email: quality@brainscope.com
• Phone: 240-752-7680
• Email: quality@brainscope.com
• Phone: 240-752-7680
• Email: quality@brainscope.com
• Phone: 240-752-7680
• Email: quality@brainscope.com
• Phone: 240-752-7680
• Email: quality@brainscope.com
• Phone: 240-752-7680
• Email: quality@brainscope.com
• Phone: 240-752-7680
• Email: quality@brainscope.com
• Phone: 240-752-7680
• Email: quality@brainscope.com
• Phone: 240-752-7680
• Email: quality@brainscope.com
• Phone: 240-752-7680
• Email: quality@brainscope.com
• Phone: 240-752-7680
• Email: quality@brainscope.com
• Phone: 240-752-7680
• Email: quality@brainscope.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852745007284 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190815

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: 2024-06-12
• Device Publish Date: 2024-06-04

On-Brand Devices [BrainScope One]

• 00852745007123: 99-1403-002
• 00852745007239: BrainScope Part Number 99-1801-100 (SKU: BSO-2001) Contains Device Identifier (DI) 0085274500722
• 00852745007284: This record is for BrainScope Part Number 99-1801-200 (SKU: BSO-3001) which is the BrainScope Ah