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 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
31 B146M10 100-0046-02 DSI Detector And Alarm, Arrhythmia 2 C6 monitor
32 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
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 Code "DRG"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00884838093218 Avalon Toco MP Transducer 867248 The device is intended to be used for monitoring and recording of, and to genera The device is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates PHILIPS Avalon Toco MP Transducer PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
2 00884838034228 Avalon CL Basestation 866074 Avalon CL Basestation. Basestation for Avalon cableless transducers with three s Avalon CL Basestation. Basestation for Avalon cableless transducers with three slots for fetal transducers and one slot for maternal parameters or range extenstion module. PHILIPS Avalon CL Base Station PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
3 00884838020672 IntelliVue CL NBP Pod 865216 IntelliVue Cableless NBP Pod, a battery-powered non-invasive blood pressure devi IntelliVue Cableless NBP Pod, a battery-powered non-invasive blood pressure device for Cableless Monitoring of patients. The IntelliVue CL NBP Pod provides non-invasive blood pressure and pulse rate via short range radio to the receiving system. IntelliVue CL NBP Pod PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
4 00884838020665 IntelliVue CL SpO2 Pod 865215 IntelliVue Cableless SpO2 Pod, a battery-powered pulse oximeter device for Cable IntelliVue Cableless SpO2 Pod, a battery-powered pulse oximeter device for Cableless Monitoring of patients. The IntelliVue CL SpO2 Pod provides arterial oxygen saturation, pulse rate and pleth wave form via short range radio to the receiving system. IntelliVue CL SpO2 Pod PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
5 00868772000181 InTouch Lite 4 InTouch Health INTOUCH TECHNOLOGIES, INC.
6 00868772000150 Lite Remote Presence System V2 InTouch Health INTOUCH TECHNOLOGIES, INC.
7 00868772000143 Lite Remote Presence System V3 20-13333 InTouch Health INTOUCH TECHNOLOGIES, INC.
8 00868772000136 Xpress Remote Presence System Version 2 20-14393 InTouch Health INTOUCH TECHNOLOGIES, INC.
9 00868772000112 Vantage Remote Presence System InTouch Health INTOUCH TECHNOLOGIES, INC.
10 00868772000105 Vita Remote Presence System 20-15973 InTouch Health INTOUCH TECHNOLOGIES, INC.
11 00865064000157 VV330 VV330 Continuous ECG Platform is a wireless recording system intended for use by VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display. The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data.The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older. Continuous ECG Platform VIVALNK, INC.
12 00863353000307 3.0 Healthcare Access Terminal BL HEALTHCARE, INC.
13 00862887000371 PM700 TelePatch CM PM700 is a small, auto triggered, or patient activated, device, pre TelePatch CM PM700 is a small, auto triggered, or patient activated, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia. TelePatch Cardiac Monitor MEDICOMP, INC.
14 00862887000357 PM500 Cardiac Monitor PM500 is a small, auto triggered, or patient activated, device, Cardiac Monitor PM500 is a small, auto triggered, or patient activated, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia. Cardiac Monitor MEDICOMP, INC.
15 00862186000386 Rosetta-Lt Data Translator 040-184-7100 The Rosetta-Lt Data Translator receives and communicates information from monito The Rosetta-Lt Data Translator receives and communicates information from monitor/defibrillators over radio/phone communications systems. GD GENERAL DEVICES
16 00862186000379 CAREpoint Workstation 040-183-4000 The CAREpoint Workstation communication console is a standard radio/telephony co The CAREpoint Workstation communication console is a standard radio/telephony communications console used for vice and data communications. Personal Computer (PC) based, it contains various means to interface to and control communications elements (i.e. 2 way radio, landline, wireless telephone) as which are commonly used for commercial and public safety (i.e. police, fire, EMS) communication purposes. GD GENERAL DEVICES
17 00860508000311 Version 3.0 Released 20160615 The Sanitas™ Clinical Care Platform is a software system that collects patient p The Sanitas™ Clinical Care Platform is a software system that collects patient physiological data (such as blood pressure and blood sugar levels) for transmission to a secure central storage server, which can be accessed by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. These data are also available to the patient for viewing purposes and as an aid in maintaining wellness regiments. The Sanitas™ Clinical Care Platform is an accessory software application that is used by patients in non-clinical settings (e.g. home), to collect, record and transmit their physiological information to a remote secure server. Stored data is accessible by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. The Sanitas Clinical Care Platform is also intended to be used in combination with a variety of external vital sign devices. The Sanitas Clinical Care Platform does not measure, interpret or make any decisions on the data that it conveys. It is not intended as a replacement for the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring. Sanitas™ Clinical Care Platform SANITAS, INC.
18 00860508000304 Version 2.0 Released 20160615 Family Healthware™ is a self-administered, interactive Web-based software tool t Family Healthware™ is a self-administered, interactive Web-based software tool that assesses a person's familial risk for six diseases (coronary heart disease, stroke, diabetes, and colorectal, breast, and ovarian cancer). It provides users with a "prevention plan" containing personalized recommendations for lifestyle changes and screening. For each person, the tool collects data about the following:+ Health behaviors (e.g., smoking and exercise);+ Screening tests (e.g., blood cholesterol and mammography);+ Health history among his or her first- and second-degree relatives.One set of algorithms in the software analyzes users' family history data and assesses their familial risk for each of the six diseases. A second set of algorithms uses the data on familial risk, health behaviors, and screening results to generate personalized prevention messages.The intended use is to utilize computerized family genomic data to increase disease risk perceptions and improve chronic disease management, thereby reducing the effects of these serious chronic disorders. Family Healthware™ SANITAS, INC.
19 00860004541707 SA-002 ANNE One is a wireless vital signs and physiological data monitoring platform th ANNE One is a wireless vital signs and physiological data monitoring platform that streams real-time biosignals including electrocardiography, acceleration, and temperature to measure vital signs such as heart rate, respiratory rate, body temperature, skin temperature, step count, and fall count. The system features two skin-mounted, bio-integrated sensors that pair with an associated proprietary software application for the display of real-time vital sign measurements. ANNE™ One SIBEL INC.
20 00860000825818 InTouch Lite 4 with Boom InTouch Health INTOUCH TECHNOLOGIES, INC.
21 00856298006305 TeleRehab Rack Server 100666 TeleRehab Rack Server SCOTTCARE CORPORATION, THE
22 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
23 00856298006282 TR620 101127 The housing used to enclose RF receiver cards for use with the TeleRehab system. TeleRehab Receiver Box SCOTTCARE CORPORATION, THE
24 00856298006275 TeleRehab Computer 101819 Computer workstation used in conjunction with TeleRehab software. TeleRehab Computer SCOTTCARE CORPORATION, THE
25 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
26 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
27 00856298006213 TeleSense Software Software used for interaction and programming of the TeleSenseRCM and TeleSense-E devices. TeleSense Software SCOTTCARE CORPORATION, THE
28 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
29 00856298006145 TeleSense 3 Lead Patient Cable 40" 101873 TeleSense 3 Lead Patient Cable 40" SCOTTCARE CORPORATION, THE
30 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
31 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
32 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
33 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
34 00856298006084 Telemetry 5 Lead Patient Cable 100234 Telemetry 5 Lead Patient Cable SCOTTCARE CORPORATION, THE
35 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
36 00856298006060 Innovo 101759 Cardiac Rehab ECG telemetry transmitter. Innovo SCOTTCARE CORPORATION, THE
37 00856298006053 DS2 91863 Cardiac Rehab ECG telemetry transmitter. Angel SCOTTCARE CORPORATION, THE
38 00856298006046 TS01 101109B 3.7V Rechargeable Lithium Polymer battery for use in TeleSentry Devices TeleSentry Battery SCOTTCARE CORPORATION, THE
39 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
40 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
41 00853023006128 CareAwareiBus5 Cerner CareAware iBus CERNER CORPORATION
42 00853023006012 CareAwareiBus6 Cerner CareAware iBus CERNER CORPORATION
43 00851725007214 EDNS-9001-AVGH977 EDNS-9001-AVGH977 Prefense - Early Detection and Notification System (Vital Signs Central) PC Prefense NKUS LAB
44 00851725007030 EDNS-WS24 EDNS-WS24 Prefense 24" display Prefense NKUS LAB
45 00851725007023 EDNS-9001 EDNS-9001 Prefense - Early Detection and Notification System (PC) Prefense NKUS LAB
46 00850490007467 8303-02 8303-02 Vista Phone A21 relay device VistaPhone VITAL CONNECT, INC.
47 00850490007450 4007-01 4007-01 VitalPatch Biosensor VitalPatch® RTM VITAL CONNECT, INC.
48 00850490007443 1400-02 1400-02 VitalConnect 14-day Cardiac Monitoring Kit VitalConnect 14-day Cardiac Monitoring Kit VITAL CONNECT, INC.
49 00850490007436 8303-01 8303-01 Vista Phone relay device VistaPhone VITAL CONNECT, INC.
50 00850490007429 8203-01 8203-01 VistaTablet Relay Device VistaTablet VITAL CONNECT, INC.