FDA.reportPublic FDA data

APK

Primary DI
06946725540763
Brand
APK
Company
APK Technology Co.,Ltd.
Model
A2610-EZ12
Device description
Electrocardiograph Electrode
Published
2025-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DRXElectrode, Electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06946725540763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06946725540763069467255407636946725540763

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode, reusableA noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, or adhesive tape, and a conductive gel (some are pre-gelled), or using a suction mechanism; alternatively, some types may be designed to be attached to hand-held heart rate meters. Electrocardiography (ECG) is usually performed using a set of electrodes (e.g., 12) connected to appropriate leads and cables. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529691989
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06946725549926APKI-A0212-SY125PUA0212-SY125PU2026-03-19
06946725549933APKI-A0212-SA126PVA0212-SA126PV2026-03-19
06946725549940APKI-A0212-SA126PUA0212-SA126PU2026-03-19
06946725549919APKI-A0212-SI125PUA0212-SI125PU2026-03-17
06946725513996APKI-A0212-SA203MVA0212-SA203MV2026-03-10
06946725514009APKI-A0212-SA203MUA0212-SA203MU2026-03-10
06946725514016APKI-A0212-SP203MVA0212-SP203MV2026-03-10
06946725514023APKI-A0212-SP203MUA0212-SP203MU2026-03-10
06946725514030APKI-A0212-SW203MUA0212-SW203MU2026-03-10
06946725514047APKI-A0212-SR203MUA0212-SR203MU2026-03-10
06946725514054APKI-A0212-SI203MUA0212-SI203MU2026-03-10
06946725514061APKI-A0212-SY203MUA0212-SY203MU2026-03-10
06946725514078APKI-A0220-SA125PVA0220-SA125PV2026-03-10
06946725514085APKI-A0220-SA125PUA0220-SA125PU2026-03-10
06946725514092APKI-A0220-SP125PVA0220-SP125PV2026-03-10
06946725514108APKI-A0220-SP125PUA0220-SP125PU2026-03-10
06946725514115APKI-A0220-SW125PUA0220-SW125PU2026-03-10
06946725514122APKI-A0220-SR125PUA0220-SR125PU2026-03-10
06946725514139APKI-A0220-SI125PUA0220-SI125PU2026-03-10
06946725514146APKI-A0220-SY125PUA0220-SY125PU2026-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850018561006ECG Patient CableINTERNATIONAL BIOMEDICAL, LTD.DRX2026-10-13
19005531000978SkintactLeonhard Lang GmbHDRX2026-10-12
20885380213202KendallCardinal Health 200, LLCDRX2026-08-18
10850078465006NIKOTRACENIKOMED USADRX2026-08-17
10850078465013NIKOTRACENIKOMED USADRX2026-08-17
10850078465020NIKOTRACENIKOMED USADRX2026-08-17
05060038511034Ambu® WhiteSensor 40554Ambu A/SDRX2026-08-07
00851491007555AccuSensorLynn Medical Instrument Co.DRX2026-07-28
00851491007562AccuSensorLynn Medical Instrument Co.DRX2026-07-24
G828HARNESS0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
00860002238500Piccolo MedicalPiccolo Medical, Inc.DRX2026-05-06
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
00860002238586Piccolo MedicalPiccolo Medical, Inc.DRX2025-11-07
10841522130755Eclipse MiniSPACELABS HEALTHCARE (WASHINGTON), INCDRX2024-06-07
20192253016632KendallCardinal Health 200, LLCDRX2024-02-28
20192253016663KendallCardinal Health 200, LLCDRX2024-02-28
20192253016670KendallCardinal Health 200, LLCDRX2024-02-28
20192253016830KendallCardinal Health 200, LLCDRX2024-02-28
20192253017424KendallCardinal Health 200, LLCDRX2024-02-28
20192253017813KendallCardinal Health 200, LLCDRX2024-02-28
20192253017080KendallCardinal Health 200, LLCDRX2023-03-16
10841522130298Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCDRX2023-02-23
20192253016748KendallCardinal Health 200, LLCDRX2021-05-19
08033003267424NAFIAB SPADRX2021-03-31
20192253016755KendallCardinal Health 200, LLCDRX2021-02-23
20192253017349KendallCardinal Health 200, LLCDRX2021-02-23
20192253017196KendallCardinal Health 200, LLCDRX2020-11-17
08906035281044Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20