FDA.reportPublic FDA data

Surelead

Primary DI
B631ADX2GE61
Brand
Surelead
Company
Authentic Medical
Model
ADX2GE6
Published
2026-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
B631ADX2GE61PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead switching adaptorA switching device to which electrocardiograph (ECG) limb and chest leads may be attached. It is used to connect various combinations of limb and chest leads to the output terminals in order to create standard lead combinations (e.g., leads I, II and III). This device will typically be used when the devices to be connected are from different manufacturer's, enabling them to mate together. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078861998
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B631DLSRPHP5L6F1SureLeadDLSRPHP5L6F2026-05-19
B631DLSRPHP5L4F1SureLeadDLSRPHP5L4F2026-03-13
B631EXTGE6PL8F1SureleadEXTGE6PL8F2026-03-13
B631TCGE2GE63M1SureleadTCGE2GE63M2026-03-13
B631TCPH2GE123M1SureleadTCPH2GE123M2025-01-28
B631ADGE2PH55SureleadADGE2PH552025-01-07
B631DLSRGE51M1SureLeadDLSRGE51M2024-11-25
B631DLSRGE53M1SureLeadDLSRGE53M2024-11-25
B631SPPDA1M1SureLeadSPPDA1M2024-11-05
B631TC400MR101SureLeadTC400MR102024-11-05
B631TSC101SureLeadTSC102024-11-05
B631TSC400101SureLeadTSC400102024-11-05
B631ADGE2PH51SureleadADGE2PH52024-10-30
B631TCGE2GE122F1SureleadTCGE2GE122F2024-10-30
B631TCGE2GE123M1SureleadTCGE2GE123M2024-10-30
B631TCGE2GE53M1SureleadTCGE2GE53M2024-10-30
B631TCGE2GE5S1SureleadTCGE2GE5S2024-10-30
B631TCPH2GE53M1SureleadTCPH2GE53M2024-10-30
B631DLSGGE4VL1M1SureLeadDLSGGE4VL1M2024-10-22
B631DLSGGE53M1SureLeadDLSGGE53M2024-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06946725571040APKAPK Technology Co.,Ltd.IKD2026-08-14