FDA.reportPublic FDA data

Ceribell EEG Headband, medium size

Primary DI
00851420007038
Brand
Ceribell EEG Headband, medium size
Company
CERIBELL, INC.
Model
C152
Published
2018-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GWQFull-Montage Standard Electroencephalograph
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171459000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171459000Ceribell Instant EEG HeadbandCeribell, Inc.2017-08-21GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851420007038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851420007038008514200070388514200070380851420007038

GMDN Terms#

Term, Definition table
TermDefinition
Analytical scalp electrode, single-useA noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk with a conductive surface (e.g., tin, gold, conductive plastic) and a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079897397
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
00851420007076Ceribell EEG Headcap, Small C2512024-03-08
00851420007083Ceribell EEG Headcap, MediumC2522024-03-08
00851420007045Pocket EEG Device, EEG Recording Viewer SoftwareSW-000012018-03-28
00851420007021Ceribell EEG Headband, small sizeC1512018-03-28
00851420007052Pocket EEG DeviceC1002021-08-02
00851420007007Pocket EEG DeviceC1002018-01-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08690020003062BrainView NeuralScanMedeia, Inc.GWQ2025-02-05
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08056446900673Neurotravel LIGHTEB NEURO SPAGWQ2024-12-04
08056446900680Neurotravel LIGHT Base UnitEB NEURO SPAGWQ2024-12-04
08056446900895BE PLUS PRO LIGHTEB NEURO SPAGWQ2024-12-04
08056446900901BE PLUS PRO STANDARDEB NEURO SPAGWQ2024-12-04
08056446900918BE PLUS PRO FULLEB NEURO SPAGWQ2024-12-04
08056446900925BE PLUS PRO ADVANCEDEB NEURO SPAGWQ2024-12-04
08056446900932BE PLUS PRO Battery PackEB NEURO SPAGWQ2024-12-04
08056446901311BE PLUS PRO [LIGHT] EB NEURO SPAGWQ2024-12-04
08056446901328BE PLUS PRO [STANDARD]EB NEURO SPAGWQ2024-12-04
08056446901335BE PLUS PRO [FULL]EB NEURO SPAGWQ2024-12-04
08056446901342BE PLUS PRO [ADVANCED]EB NEURO SPAGWQ2024-12-04
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791375591CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375614CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375638CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375652CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375676CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791374426NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374440NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374457NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374471NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374495NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374518NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374532NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374556NeuroguardTechnomed Engineering B.V.GXY2024-05-22