FDA.reportPublic FDA data

Surelead

Primary DI
B631TCSP2PH123M1
Brand
Surelead
Company
Authentic Medical
Model
TCSP2PH123M
Published
2026-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

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
B631TCSP2PH123M1PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
078861998
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B631ADSP2PH51SureleadADSP2PH52026-10-07
B631TCDR2GE510C1SureleadTCDR2GE510C2026-10-07
B631TCDRN52MRT510C1SureleadTCDRN52MRT510C2026-10-07
B631TCMXAS4C1SureleadTCMXAS4C2026-10-07
B631TCZLX2PH53M1SureleadTCZLX2PH53M2026-10-07
B631DLSRPHP5L6F1SureLeadDLSRPHP5L6F2026-05-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725572931APKAPK Technology Co.,Ltd.IKD2026-10-26
06946725502341APKAPK Technology Co.,Ltd.IKD2026-10-22
06946725500989APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500996APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501009APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501016APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501030APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501047APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501054APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501061APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501078APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501085APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501092APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501108APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501115APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501122APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501139APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501146APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501153APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501160APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501177APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501184APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501191APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501207APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501214APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501221APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501238APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501245APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501252APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501269APKAPK Technology Co.,Ltd.IKD2025-07-22