FDA.reportPublic FDA data

Ives EEG Solutions

Primary DI
00850012681113
Brand
Ives EEG Solutions
Company
IVES EEG SOLUTIONS, LLC
Model
HAR-27
Device description
Ives MR Conditional Electrode System Harness, 27 lead wire harness, MR Unsafe (disconnect from electrode set before CT or MR imaging)
Published
2019-11-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
IKDCable, Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850012681113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012681113008500126811138500126811130850012681113

GMDN Terms#

Term, Definition table
TermDefinition
Analytical scalp leadA wire(s) intended to connect an electroencephalographic electrode(s) to an electroencephalographic system to facilitate the transmission of the electrical signals captured at the site of the electrode to the system for measuring, recording, monitoring and/or analysis during encephalography (EEG); the electrodes are not included. The procedure is performed to record, monitor, and/or analyse the brain's electrical activity. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
015020106
Device count
1
Premarket exempt
true
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
00850012681007Ives EEG SolutionsDCPE-21/B2019-10-29
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
00850087490122AUVONChangsha Yuhong Trading Co., LtdIKD2026-06-08
00850087490146AUVONChangsha Yuhong Trading Co., LtdIKD2026-06-08
06978035540003SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-05
00650551006602PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
00650551006619PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
00650551006626PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
04250307612871Adapter cable touchproof for ALM Tubeinomed Medizintechnik GmbHIKD2026-05-29
04250307612888Connection cable for ALM Tubeinomed Medizintechnik GmbHIKD2026-05-29
07613327688788N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2026-04-06
07613327643237N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
07613327643244N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
03664539003559NADIXI MEDICALIKD2022-07-06
03664539003566NADIXI MEDICALIKD2022-07-06
03664539003573NADIXI MEDICALIKD2022-07-06
03664539003580NADIXI MEDICALIKD2022-07-06
03664539003603NADIXI MEDICALIKD2022-07-06
03664539003610NADIXI MEDICALIKD2022-07-06
03664539003627NADIXI MEDICALIKD2022-07-06
03664539003634NADIXI MEDICALIKD2022-07-06
08033695721525NAFIAB SPAIKD2021-07-08
08033695726278NAFIAB SPAIKD2020-06-13
08033695726995NAFIAB SPAIKD2020-06-13
08054242441734NAFIAB SPAIKD2020-06-13
08054953345864NAFIAB SPAIKD2020-06-13
08698870325334FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870325341FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870325358FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870325365FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870325372FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870328588FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22