FDA.reportPublic FDA data

Cardiostation Premier Stand Alone Software

Primary DI
B147CSS0
Brand
Cardiostation Premier Stand Alone Software
Company
UNIVERSAL MEDICAL, INC.
Model
Cardiostation Standalone Software
Device description
Cardiostation Software sold with wireless devices.
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
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
B147CSS0PrimaryHIBCC0

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
Lot or batch
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
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
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00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DXH2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2026-06-03
05419980589309FibriCheckQompiumDXH2026-05-06
05419980589316FibriCheckQompiumDXH2026-05-06
05419980589323FibriCheckQompiumDXH2026-05-06
05419980589347FibriCheckQompiumDXH2026-05-06
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DXH2026-02-11
00198953107263MACGe Medical Systems Information Technologies, Inc.DXH2026-01-27
07290008960380SmartheartSHL TELEMEDICINE INTERNATIONAL LTD.DXH2025-12-09
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
00812324000297GEMS Mobile ECGCardioComm Solutions, IncDXH2025-03-20
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
04719872981534QT ECGQt Medical, Inc.DXH2024-07-08
00856298006428EZLink-RSCOTTCARE CORPORATION, THEDXH2024-05-23
00856298006435EZLink-CSCOTTCARE CORPORATION, THEDXH2024-05-23