FDA.reportPublic FDA data

GE Healthcare

Primary DI
06947437900067
Brand
GE Healthcare
Company
SHENZHEN LAUNCH ELECTRICAL CO., LTD
Model
2104722-001
Device description
Trunk Cable 10-Lead IEC
Published
2018-01-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
06947437900067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06947437900067069474379000676947437900067

GMDN Terms#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544922461
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06947437902535Medtronic5944RL2025-02-08
06947437900265GE Healthcare2104724-0032021-05-28
06947437900272GE Healthcare2104724-0042021-05-28
06947437900289GE Healthcare2104751-0022021-05-28
06947437900296GE Healthcare2104750-0022021-05-28
06947437900302GE Healthcare2104752-0022021-05-28
06947437900319GE Healthcare2104724-0052021-05-28
06947437900326GE Healthcare2104724-0062021-05-28
06947437900333GE Healthcare2104724-0072021-05-28
06947437900340GE Healthcare58313982021-06-01
06947437900357GE Healthcare58313992021-06-01
06947437900364GE Healthcare58314002021-06-01
06947437900371GE Healthcare58314012021-06-01
06947437910431GE HealthcareMA01032020-04-27
06947437910448GE HealthcareME01032020-04-27
06947437910455GE HealthcareMA01052020-04-27
06947437910462GE HealthcareME01052020-04-27
06947437900074GE Healthcare2104723-0012018-01-22
06947437900081GE Healthcare2104724-0012018-01-22
06947437900098GE Healthcare2104724-0022018-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725572283APKAPK Technology Co.,Ltd.IKD2026-09-04
04260223147760PATH ABR ElectrodesPATH medical GmbHIKD2026-08-25
00860004773733AtriAmp - Pacing CableAtrility Medical LLCIKD2026-08-18
06946725571736APKAPK Technology Co.,Ltd.IKD2026-08-15
06946725512173APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725513521APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725555262APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568439APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568446APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568453APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568460APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568477APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568484APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568491APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568507APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568514APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568521APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568538APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568545APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568552APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568569APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568576APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568705APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568859APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569429APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569436APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569467APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569474APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725570005APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725570142APKAPK Technology Co.,Ltd.IKD2026-08-14