FDA.reportPublic FDA data

Ives EEG Solutions

Primary DI
00850012681007
Brand
Ives EEG Solutions
Company
IVES EEG SOLUTIONS, LLC
Model
DCPE-21/B
Device description
MR Conditional Disposable EEG Cup Electrode System, 21 lead, black cup, CT compatible
Published
2019-10-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071118000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071118000GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODEIves Eeg Solutions, Inc.2007-09-07GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850012681120PackageGS110Not in Commercial Distribution
10850012681004PackageGS110In Commercial Distribution
00850012681007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012681120008500126811208500126811200850012681120
1085001268100410850012681004
00850012681007008500126810078500126810070850012681007

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
015020106
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850012681236Ives EEG SolutionsDCPEX-23/SDCPEX-23/S2020-12-10
00850012681250Ives EEG SolutionsDCPEX-27/SDCPEX-27/S2020-12-10
00850012681083Ives EEG SolutionsHAR-212019-11-05
00850012681090Ives EEG SolutionsHAR-232019-11-05
00850012681106Ives EEG SolutionsHAR-252019-11-05
00850012681113Ives EEG SolutionsHAR-272019-11-05
00850012681014Ives EEG SolutionsDCPE-23/BDCPE-23/B2019-10-29
00850012681021Ives EEG SolutionsDCPE-25/B2019-10-29
00850012681038Ives EEG SolutionsDCPE-27/BDCPE-27/B2019-10-29
00850012681045Ives EEG SolutionsDCPE-21/S2019-10-29
00850012681052Ives EEG SolutionsDCPE-23/S2019-10-29
00850012681069Ives EEG SolutionsDCPE-25/S2019-10-29
00850012681076Ives EEG SolutionsDCPE-27/SDCPE-27/S2019-10-29
00850012681182Ives EEG SolutionsDCPEX-21/BDCPEX-21/B2020-11-06
00850012681229Ives EEG SolutionsDCPEX-21/SDCPEX-21/S2020-12-10
00850012681243Ives EEG SolutionsDCPEX-25/SDCPEX-25/S2020-12-10
00850012681199Ives EEG SolutionsDCPEX-23/BDCPEX-23/B2020-11-06
00850012681205Ives EEG SolutionsDCPEX-25/BDCPEX-25/B2020-11-06
00850012681212Ives EEG SolutionsDCPEX-27/BDCPEX-27/B2020-11-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720791379032Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379049Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379063Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379087Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
00816312028072Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-06-01
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
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
08720791374693MagstimTechnomed Engineering B.V.GXY2024-05-22
08720791372125CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372149CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372163CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372187CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372200CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372224CadwellTechnomed Engineering B.V.GXY2024-05-02