FDA.reportPublic FDA data

APK

Primary DI
06946725502525
Brand
APK
Company
APK Technology Co.,Ltd.
Model
I-MCB-05MB-10AS-0030
Device description
CBL 5 LD COMPATIBLE SPACELABS ONE PIECE PINCH
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
06946725502525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06946725502525069467255025256946725502525

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
06946725502457APKI-TCB-05MB-10AS-00302025-07-22
06946725502464APKI-TCB-03MC-10AS-00302025-07-22
06946725502471APKI-TCB-05MC-10AS-00302025-07-22
06946725502488APKI-TCB-05MD-10AS-00302025-07-22
06946725502495APKI-MCB-03MA-10AS-00302025-07-22
06946725502501APKI-MCB-03MB-10AS-00302025-07-22
06946725502518APKI-MCB-05MA-10AS-00302025-07-22
06946725502532APKI-RLW-03AC-24AS-00002025-07-22
06946725502549APKI-RLW-03AC-40AS-00002025-07-22
06946725502556APKI-RLW-03BC-24AS-00002025-07-22
06946725502563APKI-RLW-03BC-40AS-00002025-07-22
06946725502570APKI-RLW-05AC-24AS-00002025-07-22
06946725502587APKI-RLW-05AC-40AS-00002025-07-22
06946725502594APKI-RLW-05BC-24AS-00002025-07-22
06946725502600APKI-RLW-05BC-40AS-00002025-07-22
06946725502617APKI-RLW-10AC-24AS-00002025-07-22
06946725502624APKI-RLW-10AC-40AS-00002025-07-22
06946725502631APKI-RLW-10BC-24AS-00002025-07-22
06946725502648APKI-RLW-10BC-40AS-00002025-07-22
06946725502655APKI-RLW-05AC-24LA-00002025-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725572108APKAPK Technology Co.,Ltd.IKD2026-10-13
06946725572115APKAPK Technology Co.,Ltd.IKD2026-10-13
06946725572122APKAPK Technology Co.,Ltd.IKD2026-10-13
07613327688771N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2026-10-08
06946725571712APKAPK Technology Co.,Ltd.IKD2026-07-01
06946725500866APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500873APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500880APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500897APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500903APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500910APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500927APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500934APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500941APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500958APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500965APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500972APKAPK Technology Co.,Ltd.IKD2025-07-22
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