FDA.reportPublic FDA data

SureLead

Primary DI
B631DLSRPHP5L6F1
Brand
SureLead
Company
Authentic Medical
Model
DLSRPHP5L6F
Published
2026-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
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
B631DLSRPHP5L6F1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, single-useA collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array to assist electrode placement. This is a single-use device.

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
B631ADX2GE61SureleadADX2GE62026-03-13
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
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