FDA.reportPublic FDA data

APK

Primary DI
06946725502785
Brand
APK
Company
APK Technology Co.,Ltd.
Model
I-RLW-05BC-24RL-0000
Device description
LDW REUSE, ECG LW COMPATIBLE TRULINK, 1LEAD, PINCH, 24"AHA, (GR)
Published
2025-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
06946725502785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06946725502785069467255027856946725502785

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA 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 (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Regulatory Flags#

DUNS number
529691989
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
06946725502341APKI-MCB-03VA-10AS-01002026-10-22
06946725513606APKI-A0209-SA203PUA0209-SA203PU2026-03-10
06946725513613APKI-A0209-SP203PVA0209-SP203PV2026-03-10
06946725513620APKI-A0209-SP203PUA0209-SP203PU2026-03-10
06946725513637APKI-A0209-SW203PUA0209-SW203PU2026-03-10
06946725513644APKI-A0209-SR203PUA0209-SR203PU2026-03-10
06946725513651APKI-A0209-SI203PUA0209-SI203PU2026-03-10
06946725513668APKI-A0209-SY203PUA0209-SY203PU2026-03-10
06946725513675APKI-A0210-SA195PVA0210-SA195PV2026-03-10
06946725513682APKI-A0210-SA195PUA0210-SA195PU2026-03-10
06946725513699APKI-A0210-SP195PVA0210-SP195PV2026-03-10
06946725513705APKI-A0210-SP195PUA0210-SP195PU2026-03-10
06946725513712APKI-A0210-SW195PUA0210-SW195PU2026-03-10
06946725513729APKI-A0210-SR195PUA0210-SR195PU2026-03-10
06946725513736APKI-A0210-SI195PUA0210-SI195PU2026-03-10
06946725513743APKI-A0210-SY195PUA0210-SY195PU2026-03-10
06946725513750APKI-A0220-SA203PVA0220-SA203PV2026-03-10
06946725513767APKI-A0220-SA203PUA0220-SA203PU2026-03-10
06946725513774APKI-A0220-SP203PVA0220-SP203PV2026-03-10
06946725513781APKI-A0220-SP203PUA0220-SP203PU2026-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06946725501276APKAPK Technology Co.,Ltd.IKD2025-07-22