Baseline Headset

Basic Information

• Brand Name: Baseline Headset
• Primary DI: 00852745007253
• Version / Model: 99-1803-202
• Catalog Number: N/A
• Company Name: Brainscope Company, Inc.
• Labeler DUNS: 805670416
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-15
• Public Version: 2
• Public Version Date: 2023-09-27
• Public Version Status: Update
• Public Device Record Key: 320c350c-6057-4253-8cd0-ef11899e3204

Device Description

A variant of the electrode headset that is to be used for Baseline sessions.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OLU	Normalizing Quantitative Electroencephalograph Software	Neurology	882.1400	2
PKQ	Computerized Cognitive Assessment Aid	Neurology	882.1470	2
PIW	Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid	Neurology	882.1450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17554	Electroencephalographic electrode cap, single-use	An array of analytical scalp electrodes preconfigured within a head-worn device designed for the rapid placement and appropriate positioning of the scalp electrodes during electroencephalography (EEG). It typically consists of a cap-like device with integrated scalp electrodes, and shielded lead wires that terminate into a connector that mates with a separate cable. The device eliminates the need to glue or paste individual electrodes to the patient’s scalp. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00852745007260	GS1		25	In Commercial Distribution
Primary	00852745007253	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K161068	000