FDA.reportPublic FDA data

SureLead

Primary DI
B631DLSGDR31M1
Brand
SureLead
Company
Authentic Medical
Model
DLSGDR31M
Published
2022-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
true

Product Codes#

Code, Name table
CodeName
DSACable, Transducer And Electrode, Patient, (Including Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B631DLSGDR31M1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, single-useA collection of non-sterile, noninvasive devices intended to be used 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 includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array to assist electrode placement. It is not designed with radiolucent properties. This is a single-use 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
B631ADSP2PH51SureleadADSP2PH52026-10-07
B631TCDR2GE510C1SureleadTCDR2GE510C2026-10-07
B631TCDRN52MRT510C1SureleadTCDRN52MRT510C2026-10-07
B631TCMXAS4C1SureleadTCMXAS4C2026-10-07
B631TCZLX2PH53M1SureleadTCZLX2PH53M2026-10-07
B631TCSP2PH123M1SureleadTCSP2PH123M2026-10-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725572924APKAPK Technology Co.,Ltd.DSA2026-10-26
00884838085299Dual IBP AdapterPhilips Medizin Systeme Böblingen GmbHDSA2026-10-21
G662ME361G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
G662ME368G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
00840416607406FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607413FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607420FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607437FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607444FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
G662ME590221F1MaguireMaguire Enterprises, Inc.DSA2026-10-19
G662ME590303G1MaguireMaguire Enterprises, Inc.DSA2026-10-16
00195278840202MACGe Medical Systems Information Technologies, Inc.DSA2026-10-13
06946725572139APKAPK Technology Co.,Ltd.DSA2026-10-13
042504134004853-channel ECG ElectrodeSOMNOmedics AGDSA2026-10-09
G662ME3311MaguireMaguire Enterprises, Inc.DSA2026-10-09
G662ME3381MaguireMaguire Enterprises, Inc.DSA2026-10-09
00840416607345FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607352FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607369FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607376FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607383FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607390FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
G662ME590015H1MaguireMaguire Enterprises, Inc.DSA2026-09-24
00191506063214OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDSA2026-09-20
03700506301775INTEGRAL PROCESS Cables & LeadwiresNISSHA MEDICAL TECHNOLOGIES SASDSA2026-08-27
G662ME590032R1MaguireMaguire Enterprises, Inc.DSA2026-08-25
00840416607130FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607147FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607154FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607161FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17