FDA.reportPublic FDA data

ECAT2 Generic

Primary DI
B146ECAT2010
Brand
ECAT2 Generic
Company
BRAEMAR MANUFACTURING, LLC
Model
900-0623-01
Published
2020-07-15
Public version status
New
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
B146ECAT2010PrimaryHIBCC0

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
049529118
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838128729C6 Monitor A13, Verizon02-023862025-10-06
00884838128736C6 Monitor A13, T Mobile02-023872025-10-06
B146C6R30C6 Sensor 3.0, Rebuilt02-021242024-06-26
B146EP25R0ePatch Sensor 2.5, Rebuilt02-022512024-06-26
B146C6M20C6 Monitor UGW100-0048-022019-10-08
B146EP2510ePatch 2.5, BTH02-020452023-01-20
B146EP2520ePatch 2.5, BTI02-020462023-11-22
B146C6M60C6 Monitor A10e, Sprint02-018002023-06-15
B146C6M80C6 Monitor A13, T Mobile02-021192023-06-15
B146C6M90C6 Monitor A13, Verizon02-021182023-06-15
B146EP2R10ePatch 2.0 rebuilt02-019972022-07-13
B146C6M70C6 Monitor A10e, Verizon02-018042022-03-21
B146C6E10C6 Sensor 3.002-018462021-04-28
B146C6R10C6 Sensor 2.5 rebuilt02-018892021-03-30
B146C6R20C6 Sensor 2.0 rebuilt02-018972021-03-30
B146BTPM0BTP-1000S Monitor100-0045-022020-07-15
B146C6M40C6 Monitor02-015492020-07-15
B146EP2020ePatch 2.0 BTI02-016502020-07-15
B146C6D0C6 Sensor D02-015612019-10-08
B146C6D10C6 Sensor 02-016062019-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
B210AC0110KardiaBand SystemAlivecor, Inc.DXH2024-03-22
03700546708275Withings®WITHINGSDXH2023-09-07
03700546708435Withings®WITHINGSDXH2023-08-30
03700546708442Withings®WITHINGSDXH2023-08-30