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 B146ERW3G040 900-0614-04 DRG Transmitters And Receivers, Physiological Signal, Radiofrequency 2 ER9W 3GSM AMI
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 00853023006128 CareAwareiBus5 Cerner CareAware iBus CERNER CORPORATION
2 00853023006012 CareAwareiBus6 Cerner CareAware iBus CERNER CORPORATION
3 00851725007214 EDNS-9001-AVGH977 EDNS-9001-AVGH977 Prefense - Early Detection and Notification System (Vital Signs Central) PC Prefense NKUS LAB
4 00851725007030 EDNS-WS24 EDNS-WS24 Prefense 24" display Prefense NKUS LAB
5 00851725007023 EDNS-9001 EDNS-9001 Prefense - Early Detection and Notification System (PC) Prefense NKUS LAB
6 00850490007467 8303-02 8303-02 Vista Phone A21 relay device VistaPhone VITAL CONNECT, INC.
7 00850490007450 4007-01 4007-01 VitalPatch Biosensor VitalPatch® RTM VITAL CONNECT, INC.
8 00850490007443 1400-02 1400-02 VitalConnect 14-day Cardiac Monitoring Kit VitalConnect 14-day Cardiac Monitoring Kit VITAL CONNECT, INC.
9 00850490007436 8303-01 8303-01 Vista Phone relay device VistaPhone VITAL CONNECT, INC.
10 00850490007429 8203-01 8203-01 VistaTablet Relay Device VistaTablet VITAL CONNECT, INC.
11 00850490007412 9610 9610 Vista Solution 3 10-day Evaluation Kit Vista Solution 3 10-day Evaluation Kit VITAL CONNECT, INC.
12 00850490007399 8103-01 8103-01 Vista Tablet relay device VistaTablet VITAL CONNECT, INC.
13 00850490007382 6100-03 6100-03 User interface in the patient's room VistaPoint Software User Interface VITAL CONNECT, INC.
14 00850490007375 6200-03 6200-03 Multipatient user interface, convenience view of VistaPoint VistaCenter VITAL CONNECT, INC.
15 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.
16 00850490007344 3037-01 3047-01 VitalPatch 2.0, 7 days VitalPatch 2.0 VITAL CONNECT, INC.
17 00850490007313 9510-01 9510-01 Vista Solution® 2.0 10-day Evaluation Kit Vista Solution® 2.0 10-day Evaluation Kit VITAL CONNECT, INC.
18 00850490007306 8102-01 8102-01 VistaTablet™ 2.0 (Boxed) VistaTablet™ 2.0 (Boxed) VITAL CONNECT, INC.
19 00850490007269 9410-01 9410-01 Vista Solution® 10-day Evaluation Kit Vista Solution® 10-day Evaluation Kit VITAL CONNECT, INC.
20 00850490007252 9430-01 9430-01 Vista Solution® 30-day Monitoring Kit Vista Solution® 30-day Monitoring Kit VITAL CONNECT, INC.
21 00850490007238 3037-01 3037-01 VitalPatch 2.0, 7 days VitalPatch 2.0 VITAL CONNECT, INC.
22 00850490007214 3035-01 3035-01 VitalPatch 2.0 Single VitalPatch™ 2.0 Single VITAL CONNECT, INC.
23 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.
24 00850490007177 8001-01 8001-01 VistaHub-WiFi relay device to be used with the Vista Solution and VitalPatch biosensor. VistaHub-WiFi VITAL CONNECT, INC.
25 00850490007160 6100-01 6100-01 User interface in the patient's room VistaPoint Software User Interface VITAL CONNECT, INC.
26 00850490007146 3012-01 VitalPatch® Active Biosensor VITAL CONNECT, INC.
27 00850490007139 6200-01 6200-01 Multipatient user interface, convenience view of VistaPoint VistaCenter VITAL CONNECT, INC.
28 00850490007078 3002-01 "VitalPatch™ Active Patch VITAL CONNECT, INC.
29 00850490007054 3001-01 "VitalPatch™ Gentle Patch VITAL CONNECT, INC.
30 00850490007047 1025-01 HealthPatch® MD Module VITAL CONNECT, INC.
31 00850490007016 1002-01 HealthPatch® MD Active Patch VITAL CONNECT, INC.
32 00850490007009 1001-01 HealthPatch® MD Gentle Patch VITAL CONNECT, INC.
33 00850005949183 BIOST06040F B2-ST06-04-0-00-GY (US) The BioButton™ is a remote monitoring wearable device intended to collect physio The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data.The device is intended for use on users who are 18 years of age or older.The device does not output heart rate or respiratory rate measurements during periods of motion or activity.The device is not intended for use on critical care patients. BioButton v3 (BBN-r) BIOINTELLISENSE, INC.
34 00850005949145 BIOST05020F SKU# B2-ST05-02-0-00-GY The BioButton™ is a remote monitoring wearable device intended to collect physio The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data.The device is intended for use on users who are 18 years of age or older.The device does not output heart rate or respiratory rate measurements during periods of motion or activity.The device is not intended for use on critical care patients. BioButton v2 BIOINTELLISENSE, INC.
35 00850005949107 BIOST03020F SKU# B2-ST03-02-0-00-GY The BioButton™ is a remote monitoring wearable device intended to collect physio The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data.The device is intended for use on users who are 18 years of age or older.The device does not output heart rate or respiratory rate measurements during periods of motion or activity.The device is not intended for use on critical care patients. BioButton BIOINTELLISENSE, INC.
36 00850005949046 SWDT10001-1.1.1 Offload Software for the BioSticker System. BioSticker™ System Offload Software BIOINTELLISENSE, INC.
37 00850005949008 BIOST01021F The BioSticker™ System is a wearable remote monitoring system intended for conti The BioSticker™ System is a wearable remote monitoring system intended for continuous collection of physiological data in home and healthcare settings. BioSticker™ BIOINTELLISENSE, INC.
38 00849593016339 LS-208B 12 Lead, LeadWear, size 7L LifeSync AMC
39 00849593008297 LS-229 LeadWear, 12 Lead, Size 7L LifeSync AMC
40 00849593008228 LS-410D Patient Transceiver Kit - 2.1 LifeSync AMC
41 00849593007658 LS-420 Monitor Transceiver Kit - 2.1 LifeSync AMC
42 00849593007641 LS-410 Patient Transceiver Kit - 2.1 LifeSync AMC
43 00849593005821 LS-238B LeadWear, Precordial, Size 7L 48/Case LifeSync AMC
44 00849593005814 LS-229D 5 Lead, LeadWear, Size 9L, Taiwan LifeSync AMC
45 00849593005791 LS-228D 5 Lead, LeadWear, Size 7L, Taiwan LifeSync AMC
46 00849593005777 LS-229 5 Lead, LeadWear, Size 9L LifeSync AMC
47 00849593005753 LS-228 5 Lead, LeadWear, Size 7L LifeSync AMC
48 00849593005395 LS-410PH Patient Transceiver Philips LifeSync AMC
49 00849593005388 LS-410GE Patient Transceiver GE LifeSync AMC
50 00849593000000 AC-6X924/CCL Disp Cl Ft Poly Telepouch,24" Top String,Clip,Velcro Lock AMC AMC