FDA.reportPublic FDA data

Heartrak ECAT Patient Cable

Primary DI
B147CBECAT0
Brand
Heartrak ECAT Patient Cable
Company
UNIVERSAL MEDICAL, INC.
Model
Heartrak ECAT Patient Cable
Device description
Electrode cable
Published
2017-02-12
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
B147CBECAT0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiography telemetric monitoring systemAn assembly of devices designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
803593073
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B14731160Pacetrak Plus rev 3Pacetrak Plus rev 3 (PP3)2017-01-21
B14731161Pacetrak Plus rev 3Pacetrak Plus rev 3 (PP3)2017-01-21
B147CA0Cardiostation® Advantage SoftwareCardiostation® Advantage Software2017-02-12
B147CSS0Cardiostation Premier Stand Alone SoftwareCardiostation Standalone Software2017-02-12
B147CSTTM010Cardiostation Transtelephonic ModuleCardioStation Transtelephonic Module2017-01-21
B147EC0eCardiostation SoftwareeCardiostation Software2017-02-12
B147FSAIR0Fusion AirFusion Air2017-02-12
B147HT20Heartrak 2Heartrak 22017-01-21
B147HTECAT010Heartrak ECATHeartrak ECAT2017-01-21
B147HTECAT020Heartrak ECAT 2Heartrak ECAT 22017-01-21
B147HTSM50Heartrak Smart Rev 5Heartrak Smart Rev 52017-01-21
B147HTSMAF50Heartrak Smart AFHeartrak Smart AF2017-01-21
B147HTSMW010Heartrak Smart Wireless Rev 1Heartrak Smart Wireless Rev 12017-01-21
B147PACETRAKPLUSENR0Pacetrak Plus Rev 5Pacetrak Plus Rev 5(PP5-Pactrak Plus ENR)2017-02-12
B147PACETRAKSPEAKS0Pacetrak Plus rev 4Pacetrak Plus rev 4 (PP4-Pacetrak Plus Speaks)2017-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719872982555QT ECGQt Medical, Inc.IKD2026-10-28
50885380213234KendallCardinal Health 200, LLCIKD2026-10-28
50885380213241KendallCardinal Health 200, LLCIKD2026-10-28
50885380213258KendallCardinal Health 200, LLCIKD2026-10-28
06946725572931APKAPK Technology Co.,Ltd.IKD2026-10-26
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