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 B146ECAT2010 900-0623-01 DXH Transmitters And Receivers, Electrocardiograph, Telephone 2 ECAT2 Generic
24 B146DL9ZW0 900-0570-25 MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 DL900
25 B146DL9BD0 900-0570-20 Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 DL900 Biomedical SyS
26 B146DL95000 900-0616-00 MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 DL950 Braemar
27 B146DL9280 900-0570-28 MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 DL900
28 B146DL900 350-0290-00 IKD Cable, Electrode 2 DL900 Patient cable
29 B146CK0 100-0030-01 Holter Recorder MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 Cardiokey
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
Other products with the same Product Codes "DRG, MLO"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00860000825818 InTouch Lite 4 with Boom InTouch Health INTOUCH TECHNOLOGIES, INC.
2 00856298006305 TeleRehab Rack Server 100666 TeleRehab Rack Server SCOTTCARE CORPORATION, THE
3 00856298006299 TeleRehab Receiver Card 100007 RF Receiver card to be used in the TeleRehab Receiver Box to receive RF data tra RF Receiver card to be used in the TeleRehab Receiver Box to receive RF data transmission from transmitters. TeleRehab Receiver Card SCOTTCARE CORPORATION, THE
4 00856298006282 TR620 101127 The housing used to enclose RF receiver cards for use with the TeleRehab system. TeleRehab Receiver Box SCOTTCARE CORPORATION, THE
5 00856298006275 TeleRehab Computer 101819 Computer workstation used in conjunction with TeleRehab software. TeleRehab Computer SCOTTCARE CORPORATION, THE
6 00856298006251 TeleRehab Software Work Station/Seat License 101608 The ScottCare VersaCare Cardiopulmonary Monitoring System is designed to allow m The ScottCare VersaCare Cardiopulmonary Monitoring System is designed to allow monitoring andrecording of electrocardiograph (ECG) rhythm strips and related information for patients undergoingan exercise therapy program. Patients are monitored by medical telemetry exercise monitoringequipment. This feature allows patients to comply with exercise prescriptions while exercising at amedical/rehabilitation facility near their home, or by returning to the primary medical facility toparticipate in an in-house cardiopulmonary rehabilitation program. VersaCare includes a ProgramManagement module that prints a variety of reports. TeleRehab Software Work Station/Seat License SCOTTCARE CORPORATION, THE
7 00856298006244 TeleRehab Software File Manager 101601 The ScottCare VersaCare Cardiopulmonary Monitoring System is designed to allow m The ScottCare VersaCare Cardiopulmonary Monitoring System is designed to allow monitoring andrecording of electrocardiograph (ECG) rhythm strips and related information for patients undergoingan exercise therapy program. Patients are monitored by medical telemetry exercise monitoringequipment. This feature allows patients to comply with exercise prescriptions while exercising at amedical/rehabilitation facility near their home, or by returning to the primary medical facility toparticipate in an in-house cardiopulmonary rehabilitation program. VersaCare includes a ProgramManagement module that prints a variety of reports. TeleRehab Software File Manager SCOTTCARE CORPORATION, THE
8 00856298006213 TeleSense Software Software used for interaction and programming of the TeleSenseRCM and TeleSense-E devices. TeleSense Software SCOTTCARE CORPORATION, THE
9 00856298006152 TeleSense/Chroma2 Download Cable 101825 USB cable designed to connect with TeleSenseRCM, TeleSense-E, and Chroma2 device USB cable designed to connect with TeleSenseRCM, TeleSense-E, and Chroma2 devices to download device data. TeleSense/Chroma2 Download Cable SCOTTCARE CORPORATION, THE
10 00856298006145 TeleSense 3 Lead Patient Cable 40" 101873 TeleSense 3 Lead Patient Cable 40" SCOTTCARE CORPORATION, THE
11 00856298006138 TeleSense 3 Lead Patient Cable 30" 101826 30" 3 lead ECG patient cable for use with the TeleSenseRCM or TeleSense-E devices. TeleSense 3 Lead Patient Cable 30" SCOTTCARE CORPORATION, THE
12 00856298006121 TeleSentry 3 Lead Patient Cable 100172 ECG 3 lead patient cable for use with TeleSentry Devices TeleSentry 3 Lead Patient Cable SCOTTCARE CORPORATION, THE
13 00856298006107 Chroma2 7 Lead Patient Cable 101928 5 lead ECG patient cable to be used with the Chroma2 device. Chroma2 7 Lead Patient Cable SCOTTCARE CORPORATION, THE
14 00856298006091 Chroma2 5 Lead Patient Cable 5 lead ECG patient cable to be used with the Chroma2 device. Chroma2 5 Lead Patient Cable SCOTTCARE CORPORATION, THE
15 00856298006084 Telemetry 5 Lead Patient Cable 100234 Telemetry 5 Lead Patient Cable SCOTTCARE CORPORATION, THE
16 00856298006077 Telemetry 3 Lead Patient Cable 100233 Cardiac Rehab 3 Lead patient cable used to connect to Angel and Innovo transmitters. Telemetry 3 Lead Patient Cable SCOTTCARE CORPORATION, THE
17 00856298006060 Innovo 101759 Cardiac Rehab ECG telemetry transmitter. Innovo SCOTTCARE CORPORATION, THE
18 00856298006053 DS2 91863 Cardiac Rehab ECG telemetry transmitter. Angel SCOTTCARE CORPORATION, THE
19 00856298006046 TS01 101109B 3.7V Rechargeable Lithium Polymer battery for use in TeleSentry Devices TeleSentry Battery SCOTTCARE CORPORATION, THE
20 00856298006039 E1774 101839 The TeleSense device is intended for diagnostic evaluation of patients who exper The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms orasymptomatic events that may suggest cardiac arrhythmia. The device continuously monitors and records thedata, automatically records events triggered by an arrhythmia detection algorithm or manually by the patient, andautomatically transmits the recorded event activity associated with these symptoms for review by a licensedphysician.The TeleSense is a battery powered device to be used to measure, record, store and/or remotely transfer theElectrocardiogram (ECG) noninvasively in mobile patients. The available data transfer methods are USB and Wi-Fi.TeleSense is not limited to certain patient groups or pathologies; however, the TeleSense is not intended forpediatric use. Examples of applications are:- Cardiology- Pulmonary Care- Home Care- General PractitionersContraindications:a. Patients with potentially life-threatening arrhythmias who require inpatient monitoring.b. Patients who the attending physician thinks should be hospitalized. TeleSense-E SCOTTCARE CORPORATION, THE
21 00856298006022 MCT1774 101838 The TeleSense device is intended for diagnostic evaluation of patients who exper The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms orasymptomatic events that may suggest cardiac arrhythmia. The device continuously monitors and records thedata, automatically records events triggered by an arrhythmia detection algorithm or manually by the patient, andautomatically transmits the recorded event activity associated with these symptoms for review by a licensedphysician.The TeleSense is a battery powered device to be used to measure, record, store and/or remotely transfer theElectrocardiogram (ECG) noninvasively in mobile patients. The available data transfer methods are USB and Wi-Fi.TeleSense is not limited to certain patient groups or pathologies; however, the TeleSense is not intended forpediatric use. Examples of applications are:- Cardiology- Pulmonary Care- Home Care- General PractitionersContraindications:a. Patients with potentially life-threatening arrhythmias who require inpatient monitoring.b. Patients who the attending physician thinks should be hospitalized. TeleSenseRCM SCOTTCARE CORPORATION, THE
22 00853023006128 CareAwareiBus5 Cerner CareAware iBus CERNER CORPORATION
23 00853023006012 CareAwareiBus6 Cerner CareAware iBus CERNER CORPORATION
24 00851725007214 EDNS-9001-AVGH977 EDNS-9001-AVGH977 Prefense - Early Detection and Notification System (Vital Signs Central) PC Prefense NKUS LAB
25 00851725007030 EDNS-WS24 EDNS-WS24 Prefense 24" display Prefense NKUS LAB
26 00851725007023 EDNS-9001 EDNS-9001 Prefense - Early Detection and Notification System (PC) Prefense NKUS LAB
27 00850490007467 8303-02 8303-02 Vista Phone A21 relay device VistaPhone VITAL CONNECT, INC.
28 00850490007450 4007-01 4007-01 VitalPatch Biosensor VitalPatch® RTM VITAL CONNECT, INC.
29 00850490007443 1400-02 1400-02 VitalConnect 14-day Cardiac Monitoring Kit VitalConnect 14-day Cardiac Monitoring Kit VITAL CONNECT, INC.
30 00850490007436 8303-01 8303-01 Vista Phone relay device VistaPhone VITAL CONNECT, INC.
31 00850490007429 8203-01 8203-01 VistaTablet Relay Device VistaTablet VITAL CONNECT, INC.
32 00850490007412 9610 9610 Vista Solution 3 10-day Evaluation Kit Vista Solution 3 10-day Evaluation Kit VITAL CONNECT, INC.
33 00850490007399 8103-01 8103-01 Vista Tablet relay device VistaTablet VITAL CONNECT, INC.
34 00850490007382 6100-03 6100-03 User interface in the patient's room VistaPoint Software User Interface VITAL CONNECT, INC.
35 00850490007375 6200-03 6200-03 Multipatient user interface, convenience view of VistaPoint VistaCenter VITAL CONNECT, INC.
36 00850490007368 8102-01 8102-01 VistaTablet is a tablet which will be running the VistaPoint software user inter VistaTablet is a tablet which will be running the VistaPoint software user interface in a Web container VistaTablet™ 2.0 RELAY (W/O VCI Box) VITAL CONNECT, INC.
37 00850490007344 3037-01 3047-01 VitalPatch 2.0, 7 days VitalPatch 2.0 VITAL CONNECT, INC.
38 00850490007313 9510-01 9510-01 Vista Solution® 2.0 10-day Evaluation Kit Vista Solution® 2.0 10-day Evaluation Kit VITAL CONNECT, INC.
39 00850490007306 8102-01 8102-01 VistaTablet™ 2.0 (Boxed) VistaTablet™ 2.0 (Boxed) VITAL CONNECT, INC.
40 00850490007269 9410-01 9410-01 Vista Solution® 10-day Evaluation Kit Vista Solution® 10-day Evaluation Kit VITAL CONNECT, INC.
41 00850490007252 9430-01 9430-01 Vista Solution® 30-day Monitoring Kit Vista Solution® 30-day Monitoring Kit VITAL CONNECT, INC.
42 00850490007238 3037-01 3037-01 VitalPatch 2.0, 7 days VitalPatch 2.0 VITAL CONNECT, INC.
43 00850490007214 3035-01 3035-01 VitalPatch 2.0 Single VitalPatch™ 2.0 Single VITAL CONNECT, INC.
44 00850490007207 8101-01 8101-01 VistaTablet is a tablet which will be running the VistaPoint software user inter VistaTablet is a tablet which will be running the VistaPoint software user interface in a Web container VistaTablet VITAL CONNECT, INC.
45 00850490007177 8001-01 8001-01 VistaHub-WiFi relay device to be used with the Vista Solution and VitalPatch biosensor. VistaHub-WiFi VITAL CONNECT, INC.
46 00850490007160 6100-01 6100-01 User interface in the patient's room VistaPoint Software User Interface VITAL CONNECT, INC.
47 00850490007146 3012-01 VitalPatch® Active Biosensor VITAL CONNECT, INC.
48 00850490007139 6200-01 6200-01 Multipatient user interface, convenience view of VistaPoint VistaCenter VITAL CONNECT, INC.
49 00850490007078 3002-01 "VitalPatch™ Active Patch VITAL CONNECT, INC.
50 00850490007054 3001-01 "VitalPatch™ Gentle Patch VITAL CONNECT, INC.