FDA.reportPublic FDA data

BrainScope One

Primary DI
00852745007284
Brand
BrainScope One
Company
Brainscope Company, Inc.
Model
Ahead 500 CUBC1
Catalog number
BSO-3001
Device description
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)
Published
2024-06-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLUNormalizing Quantitative Electroencephalograph Software
PIWBrain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
PKQComputerized Cognitive Assessment Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLUNormalizing Quantitative Electroencephalograph SoftwareNeurology2
PIWBrain Injury Adjunctive Interpretive Electroencephalograph Assessment AidNeurology2
PKQComputerized Cognitive Assessment AidNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190815000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190815000BrainScope TBIBrainscope Company, Inc.2019-09-11PIW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852745007284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852745007284008527450072848527450072840852745007284

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographAn electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
240-752-7680quality@brainscope.com

Regulatory Flags#

DUNS number
805670416
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852745007017Ahead 300 International Charging Kit99-1403-0282018-09-24
00852745007031Ahead Electrode Headset99-1403-2022018-09-24
00852745007062Electrode Headset99-1403-2022018-09-24
00852745007093BrainScope One International Charging Kit99-1403-0282018-09-24
00852745007253Baseline Headset99-1803-202N/A2021-11-15
00852745007239BrainScope OneAhead 500BSO-20012021-02-16
00852745007024Ahead 30099-1403-0022018-09-24
00852745007123BrainScope One99-1403-0022018-09-24
00852745007260Baseline Headset99-1803-202N/A2021-11-15
00852745007109Ahead 300 International Charging Kit99-1403-0282018-09-24
00852745007130BrainScope One International Charging Kit99-1403-0282018-09-24
00852745007048Ahead Electrode Headset99-1403-2022018-09-24
00852745007079Electrode Headset99-1403-2022018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09357225002014Nurochek-Pro HeadsetHEADSAFE MFG PTY LTDPIW2026-03-18
09357225000041Nurochek-ProHEADSAFE MFG PTY LTDPIW2026-01-23
09357225000034Nurochek-ProHEADSAFE MFG PTY LTDPIW2025-12-15
09357225001017Nurochek-Pro HeadsetHEADSAFE MFG PTY LTDPIW2025-12-15
09357225002021Nurochek-Pro Application HEADSAFE MFG PTY LTDPIW2025-12-15
09357225002038Nurochek-Pro ServerHEADSAFE MFG PTY LTDPIW2025-12-15
09357225003028Nurochek-Pro Soft Sensor KitHEADSAFE MFG PTY LTDPIW2025-12-15
09357225006029Nurochek-Pro Saline SolutionHEADSAFE MFG PTY LTDPIW2025-12-15
00852745007253Baseline HeadsetBrainscope Company, Inc.OLU2021-11-15
00852745007253Baseline HeadsetBrainscope Company, Inc.PKQ2021-11-15
00852745007253Baseline HeadsetBrainscope Company, Inc.PIW2021-11-15
00852745007260Baseline HeadsetBrainscope Company, Inc.OLU2021-11-15
00852745007239BrainScope OneBrainscope Company, Inc.PIW2021-02-16
00852745007239BrainScope OneBrainscope Company, Inc.OLU2021-02-16
00852745007239BrainScope OneBrainscope Company, Inc.PKQ2021-02-16
00860000564007Cognivue Advanced with CartCOGNIVUE, INC.PKQ2020-04-10
00860000564014Cognivue Advanced DesktopCOGNIVUE, INC.PKQ2020-04-10
EBCI80600cortiQ PROg.tec medical engineering GmbHOLU2020-03-06
00852745007017Ahead 300 International Charging KitBrainscope Company, Inc.PIW2018-09-24
00852745007017Ahead 300 International Charging KitBrainscope Company, Inc.PKQ2018-09-24
00852745007017Ahead 300 International Charging KitBrainscope Company, Inc.OLU2018-09-24
00852745007031Ahead Electrode HeadsetBrainscope Company, Inc.PKQ2018-09-24
00852745007031Ahead Electrode HeadsetBrainscope Company, Inc.PIW2018-09-24
00852745007031Ahead Electrode HeadsetBrainscope Company, Inc.OLU2018-09-24
00852745007062Electrode HeadsetBrainscope Company, Inc.PIW2018-09-24
00852745007062Electrode HeadsetBrainscope Company, Inc.PKQ2018-09-24
00852745007062Electrode HeadsetBrainscope Company, Inc.OLU2018-09-24
00852745007093BrainScope One International Charging KitBrainscope Company, Inc.PIW2018-09-24
00852745007093BrainScope One International Charging KitBrainscope Company, Inc.OLU2018-09-24
00852745007093BrainScope One International Charging KitBrainscope Company, Inc.PKQ2018-09-24