Baseline Headset

Primary DI
00852745007260
Brand
Baseline Headset
Company
Brainscope Company, Inc.
Model
99-1803-202
Catalog number
N/A
Device description
A variant of the electrode headset that is to be used for Baseline sessions.
Published
2021-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLUNormalizing Quantitative Electroencephalograph Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLUNormalizing Quantitative Electroencephalograph SoftwareNeurology2

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
00852745007260PackageGS125In Commercial Distribution
00852745007253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852745007260008527450072608527450072600852745007260
00852745007253008527450072538527450072530852745007253

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
805670416
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
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
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
00852745007284BrainScope OneBrainscope Company, Inc.OLU2024-06-04
00852745007253Baseline HeadsetBrainscope Company, Inc.OLU2021-11-15
00852745007239BrainScope OneBrainscope Company, Inc.OLU2021-02-16
EBCI80600cortiQ PROg.tec medical engineering GmbHOLU2020-03-06
00852745007017Ahead 300 International Charging KitBrainscope Company, Inc.OLU2018-09-24
00852745007031Ahead Electrode HeadsetBrainscope Company, Inc.OLU2018-09-24
00852745007062Electrode HeadsetBrainscope Company, Inc.OLU2018-09-24
00852745007093BrainScope One International Charging KitBrainscope Company, Inc.OLU2018-09-24
00852745007109Ahead 300 International Charging KitBRAINSCOPE COMPANY, INC.OLU2018-09-24
00852745007024Ahead 300Brainscope Company, Inc.OLU2018-09-24
00852745007048Ahead Electrode HeadsetBRAINSCOPE COMPANY, INC.OLU2018-09-24
00852745007079Electrode HeadsetBRAINSCOPE COMPANY, INC.OLU2018-09-24
00852745007130BrainScope One International Charging KitBRAINSCOPE COMPANY, INC.OLU2018-09-24
00852745007123BrainScope OneBrainscope Company, Inc.OLU2018-09-24