Other products from "BRAEMAR MANUFACTURING, LLC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 B146FUSB0 900-0584-10 Wireless Ambulatory ECG Arrhythmia Monitoring system DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 Fusion Braemar
2 B146EP030 900-0632-01 DSH Recorder, Magnetic Tape, Medical 2 Epatch sensor
3 B146DL9RA0 900-0570-14 Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 DL900 Remote Analysis
4 B146DL9B70 900-0570-16 Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 DL900 Braemar 7day
5 B146DL9510 350-0318-01 IKD Cable, Electrode 2 DL950 Patient Cable
6 B146C6R20 02-01897 DSI Detector And Alarm, Arrhythmia 2 C6 Sensor 2.0 rebuilt
7 B146C6D10 02-01606 DSI Detector And Alarm, Arrhythmia 2 C6 Sensor
8 B146C5M20 02-00116 DSI Detector And Alarm, Arrhythmia 2 C5 Monitor NOBT
9 B146PERP0 900-0553-06 ENHANCED ALGORITHM ECG EVENT RECORDER MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 PER900 Preventice
10 B146PE2C0 02-01639 DRX Electrode, Electrocardiograph 2 Universal CE electrode-patch
11 B146FUSFCM0 900-0584-50 Wireless Ambulatory ECG Arrhythmia Monitoring system DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 Fusion First Call Medical
12 B146ERW3G030 900-0614-03 DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER9W 3GSM Life Support
13 B146ER9WLS0 900-0581-44 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W Life Support
14 B146ER9WFCM0 900-0581-57 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W First-Call Medical
15 B146ER9WCL0 900-0581-58 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W CardioLabs
16 B146EPE30 390-0240-02 IKD Cable, Electrode ePatch electrode-patch
17 B146EP2R10 02-01997 DSH Recorder, Magnetic Tape, Medical 2 ePatch 2.0 rebuilt
18 B146EP2020 02-01650 DSH Recorder, Magnetic Tape, Medical 2 ePatch 2.0 BTI
19 B146EP080 900-0632-05 DSH Recorder, Magnetic Tape, Medical 2 Epatch Sensor
20 B146EP070 900-0632-04 DSH Recorder, Magnetic Tape, Medical 2 Epatch Sensor
21 B146EP060 900-0632-03 DSH Recorder, Magnetic Tape, Medical 2 Epatch Sensor
22 B146EP04 900-0632-02 DSH Recorder, Magnetic Tape, Medical 2 Epatch Sensor
23 B146DL9ZW0 900-0570-25 MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 DL900
24 B146DL9BD0 900-0570-20 Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 DL900 Biomedical SyS
25 B146DL95000 900-0616-00 MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 DL950 Braemar
26 B146DL9280 900-0570-28 MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 DL900
27 B146DL900 350-0290-00 IKD Cable, Electrode 2 DL900 Patient cable
28 B146CK0 100-0030-01 Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 Cardiokey
29 B146ERWCD040 900-0612-04 DRG,MLO Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiogr Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiograph, Ambulatory, With Analysis Algorithm 2 ER9W Cardiolabs
30 B146M10 100-0046-02 DSI Detector And Alarm, Arrhythmia 2 C6 monitor
31 B146ERW3GCN0 900-0614-01 DRG,MLO Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiogr Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiograph, Ambulatory, With Analysis Algorithm 2 ER9W wEvent 3GSM
32 B146ERW3G040 900-0614-04 DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER9W 3GSM AMI
33 B146ER9WES0 900-0581-55 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W Empire Scanning
34 B146ER9WCM0 900-0581-06 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W Cardiomedix
35 B146ER9WCL20 900-0581-35 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W Cardiolabs
36 B146ER9WB0 900-0581-00 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W Braemar
37 B146ER9R0 900-0557-06 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& ENHANCED ALGORITHM ECG EVENT RECORDER MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ER920 Rozinn
38 B146DL9BS0 900-0570-26 Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 DL900 Base
39 B146DL9BK0 900-0570-19 Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 DL900 Burdick 4250
40 B146DL9AT0 900-0570-12 Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 DL900 Amedtec SD
41 B146DL8CN0 900-0543-15 Holter Monitor MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 DL800 CardioNet
42 B146DL830 350-0235-03 IKD Cable, Electrode 2 DL800 Patient Cable
43 B146DL800 350-0235-00 IKD Cable, Electrode 2 DL800 Patient Cable
44 B146C6E10 02-01846 DSI Detector And Alarm, Arrhythmia 2 C6 Sensor 3.0
45 B146C6D0 02-01561 DSI Detector And Alarm, Arrhythmia 2 C6 Sensor D
46 B146C5M0 100-0025-01 Ambulatory ECG Monitoring system DSI Detector And Alarm, Arrhythmia 2 C5 Monitor
47 B146BTPL210 02-01560 DSI Detector And Alarm, Arrhythmia 2 BTP-1000L-2 BTI
48 B146PERB0 900-0553-03 ENHANCED ALGORITHM ECG EVENT RECORDER MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 PER900 Braemar
49 B146UNM0 900-0581-56 Wireless Arrhythmia Event Recorder DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER920W UNM
50 B146ER9RAF0 900-0557-07 ENHANCED ALGORITHM ECG EVENT RECORDER MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ER920 Rozinn, AFIB
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23 00613994371751 D4PCIUGCII BOARD D4PCIUGCII PACEART DIALOGIC V/SPCH NA MEDTRONIC, INC.
24 00073796267902 BP7900 BP7900 Blood Pressure Monitor and single channel EKG device. Complete Blood Pressure Monitor +EKG OMRON HEALTHCARE, INC.
25 B635BIOFLUX1A0 1.0 BIOFLUX BIOTRICITY INC
26 B635BIOFLUX100 1.0 BIOFLUX BIOTRICITY INC
27 B287ECG01U0 ECG01-U ECG01-Universal The ECG Check is intended for self-testing by patients at home. This 1-leadcardi The ECG Check is intended for self-testing by patients at home. This 1-leadcardiac monitor allows remote patients to display and transmit their EGG data tomedical professionals via a communication device to a remote server.Specifically, the EGG Check is indicated for patients who are concerned abouttheir heart rhythm and have experienced the following symptoms that aresuggestive of abnormal heart rhythms:* Skipped Beats* Pounding Heart (Palpitations)* Heart Racing or Irregular Pulse* Lightheadedness or Faintness* History of ArrhythmiasPrescription ECG Check CARDIAC DESIGNS INC.
28 B210AC0210 AC-021 The AliveCor KardiaMobile Card System is a single-channel electrocardiogram (ECG The AliveCor KardiaMobile Card System is a single-channel electrocardiogram (ECG) device that is intended to record, store, transfer, display, and analyze single-channel ECG rhythms. KardiaMobile Card ALIVECOR, INC.
29 B210AC0190 AC-019 KardiaMobile 6L ALIVECOR, INC.
30 B210AC0090 AC-009 Kardia Mobile ALIVECOR, INC.
31 B147PACETRAKSPEAKS0 Pacetrak Plus rev 4 (PP4-Pacetrak Plus Speaks) Transmitters and Receivers, Electrocardiograph, Telephone Pacetrak Plus rev 4 UNIVERSAL MEDICAL, INC.
32 B147PACETRAKPLUSENR0 Pacetrak Plus Rev 5(PP5-Pactrak Plus ENR) Transmitters and Receivers, Electrocardiograph, Telephone Pacetrak Plus Rev 5 UNIVERSAL MEDICAL, INC.
33 B147HTSMW010 Heartrak Smart Wireless Rev 1 Transmitters and Receivers, Electrocardiograph, Telephone Heartrak Smart Wireless Rev 1 UNIVERSAL MEDICAL, INC.
34 B147HTSMAF50 Heartrak Smart AF Transmitters and Receivers, Electrocardiograph, Telephone Heartrak Smart AF UNIVERSAL MEDICAL, INC.
35 B147HTSM50 Heartrak Smart Rev 5 Transmitters and Receivers, Electrocardiograph, Telephone Heartrak Smart Rev 5 UNIVERSAL MEDICAL, INC.
36 B147HTECAT020 Heartrak ECAT 2 Transmitters and Receivers, Electrocardiograph, Telephone Heartrak ECAT 2 UNIVERSAL MEDICAL, INC.
37 B147HTECAT010 Heartrak ECAT Transmitters and Receivers, Electrocardiograph, Telephone Heartrak ECAT UNIVERSAL MEDICAL, INC.
38 B147HT20 Heartrak 2 Telephone electrocardiograph transmitter and receiver Heartrak 2 UNIVERSAL MEDICAL, INC.
39 B147FSAIR0 Fusion Air Transmitters and Receivers, Electrocardiograph, Telephone Fusion Air UNIVERSAL MEDICAL, INC.
40 B147EC0 eCardiostation Software Software with CardioStation eCardiostation Software UNIVERSAL MEDICAL, INC.
41 B147CSTTM010 CardioStation Transtelephonic Module Transmitters and Receivers, Electrocardiograph, Telephone Cardiostation Transtelephonic Module UNIVERSAL MEDICAL, INC.
42 B147CSS0 Cardiostation Standalone Software Cardiostation Software sold with wireless devices. Cardiostation Premier Stand Alone Software UNIVERSAL MEDICAL, INC.
43 B147CA0 Cardiostation® Advantage Software Cardiostation Software sold with TTM module. Cardiostation® Advantage Software UNIVERSAL MEDICAL, INC.
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