FDA.reportPublic FDA data

Electrode Headset

Primary DI
00852745007062
Brand
Electrode Headset
Company
Brainscope Company, Inc.
Model
99-1403-202
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
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
K161068000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161068000Ahead 300Brainscope Company, Inc.2016-09-22PIW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852745007079PackageGS125In Commercial Distribution
00852745007147PackageGS125In Commercial Distribution
00852745007154PackageGS110In Commercial Distribution
00852745007062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852745007079008527450070798527450070790852745007079
00852745007147008527450071478527450071470852745007147
00852745007154008527450071548527450071540852745007154
00852745007062008527450070628527450070620852745007062

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic electrode cap, single-useAn 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.

Contacts#

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

Regulatory Flags#

DUNS number
805670416
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
00852745007093BrainScope One International Charging Kit99-1403-0282018-09-24
00852745007253Baseline Headset99-1803-202N/A2021-11-15
00852745007284BrainScope OneAhead 500 CUBC1BSO-30012024-06-04
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
00852745007284BrainScope OneBrainscope Company, Inc.OLU2024-06-04
00852745007284BrainScope OneBrainscope Company, Inc.PKQ2024-06-04
00852745007284BrainScope OneBrainscope Company, Inc.PIW2024-06-04
00852745007253Baseline HeadsetBrainscope Company, Inc.PKQ2021-11-15
00852745007253Baseline HeadsetBrainscope Company, Inc.OLU2021-11-15
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.PKQ2021-02-16
00852745007239BrainScope OneBrainscope Company, Inc.OLU2021-02-16
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.OLU2018-09-24
00852745007017Ahead 300 International Charging KitBrainscope Company, Inc.PKQ2018-09-24
00852745007031Ahead Electrode HeadsetBrainscope Company, Inc.OLU2018-09-24
00852745007031Ahead Electrode HeadsetBrainscope Company, Inc.PKQ2018-09-24
00852745007031Ahead Electrode HeadsetBrainscope Company, Inc.PIW2018-09-24
00852745007093BrainScope One International Charging KitBrainscope Company, Inc.OLU2018-09-24
00852745007093BrainScope One International Charging KitBrainscope Company, Inc.PIW2018-09-24
00852745007093BrainScope One International Charging KitBrainscope Company, Inc.PKQ2018-09-24