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
06946725572283APKAPK Technology Co.,Ltd.IKD2026-09-04
04260223147760PATH ABR ElectrodesPATH medical GmbHIKD2026-08-25
00860004773733AtriAmp - Pacing CableAtrility Medical LLCIKD2026-08-18
06946725571736APKAPK Technology Co.,Ltd.IKD2026-08-15
06946725512173APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725513521APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725555262APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568439APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568446APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568453APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568460APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568477APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568484APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568491APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568507APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568514APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568521APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568538APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568545APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568552APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568569APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568576APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568705APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568859APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569429APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569436APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569467APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569474APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725570005APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725570142APKAPK Technology Co.,Ltd.IKD2026-08-14