FDA.reportPublic FDA data

Heartrak Smart Rev 5

Primary DI
B147HTSM50
Brand
Heartrak Smart Rev 5
Company
UNIVERSAL MEDICAL, INC.
Model
Heartrak Smart Rev 5
Device description
Transmitters and Receivers, Electrocardiograph, Telephone
Published
2017-01-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DXHTransmitters And Receivers, Electrocardiograph, Telephone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXHTransmitters And Receivers, Electrocardiograph, TelephoneCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B147HTSM50PrimaryHIBCC0

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
Serial number
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
B147CBECAT0Heartrak ECAT Patient CableHeartrak ECAT Patient Cable2017-02-12
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
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

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Primary DI, Brand, Company table
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00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2026-06-03
05419980589309FibriCheckQompiumDXH2026-05-06
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05419980589323FibriCheckQompiumDXH2026-05-06
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00198953107263MACGe Medical Systems Information Technologies, Inc.DXH2026-01-27
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04719872981756QT ECGQt Medical, Inc.DXH2025-05-12
B353UB22511UbiqVue HolterLifesignals, Inc.DXH2025-04-22
B353UA2251R1UbiqVue Lifesignals, Inc.DXH2025-04-22
00195278421456CAMGE Medical Systems Information Technologies, Inc.DXH2025-04-07
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B210AC0290K1000Alivecor, Inc.DXH2025-03-18
00840682144322MACGE Medical Systems Information Technologies, Inc.DXH2025-03-13
00860006382308SENSINEL™ CPM REPLACEMENT ADHESIVE PADAnalog Devices, Inc.DXH2025-03-13
00860006382315SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2025-03-13
00860006382322SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DXH2025-03-13
00860006382339SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DXH2025-03-13
00860006382346SENSINEL™ CPM ALIGNMENT TOOLAnalog Devices, Inc.DXH2025-03-13
20860006382302SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack)Analog Devices, Inc.DXH2025-03-13
08908013617128Frontier X PlusFOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITEDDXH2025-02-07
00850043907046Zio ECG Utilization Software (ZEUS) SystemIRHYTHM TECHNOLOGIES, INC.DXH2024-07-26
04719872981527QT ECGQt Medical, Inc.DXH2024-07-08
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00856298006428EZLink-RSCOTTCARE CORPORATION, THEDXH2024-05-23
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