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 B595L2050G0 L2050G Adapter L2050G The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use b The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure, and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.The Vios Chest Sensor and Adapter are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients. Vios Montioring System Adapter MURATA VIOS PRIVATE LIMITED
2 B595CS20500 CS2050 Chest Sensor CS2050 The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use b The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure, and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.The Vios Chest Sensor and Adapter are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients. Vios Monitoring System Chest Sensor MURATA VIOS PRIVATE LIMITED
3 B595BSM20500 BSM2050 Software BSM2050 The Vios Monitoring System (VMS) Bedside Monitor is intended for use by medicall The Vios Monitoring System (VMS) Bedside Monitor is intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure, and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.The VMS Bedside Monitor is intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients. Vios Monitoring System Bedside Monitor MURATA VIOS PRIVATE LIMITED
4 B493SW0028 SW-0028 Web application BioStamp nPoint™ MC10, INC.
5 B493SW0027 SW-0027 Investigator application for Android BioStamp nPoint™ MC10, INC.
6 B493SW0026 SW-0027 Sync application for Android BioStamp nPoint™ MC10, INC.
7 B493SW0025 SW-0025 Link application for Android BioStamp nPoint™ MC10, INC.
8 B493MC0015 MC-0015 MC-0015 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05 BioStamp nPoint™ MC10, INC.
9 B493MC0014 MC-0014 MC-0014 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BRCT01, B493B MC-0014 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BRCT01, B493BSPS01, B493BRCA05 BioStamp nPoint™ MC10, INC.
10 B493MC0013 MC-0013 MC-0013 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05 BioStamp nPoint™ MC10, INC.
11 B493MC0012 MC-0012 MC-0012 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05 BioStamp nPoint™ MC10, INC.
12 B493MC0008 MC-0008 MC-0008 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05 BioStamp nPoint™ MC10, INC.
13 B493MC0007 MC-0007 MC-0007 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BRCT01, B493B MC-0007 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BRCT01, B493BSPS01, B493BRCA05 BioStamp nPoint™ MC10, INC.
14 B493MC0006 MC-0006 MC-0006 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05 BioStamp nPoint™ MC10, INC.
15 B493MC0005 MC-0005 MC-0005 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05 BioStamp nPoint™ MC10, INC.
16 B493MC0004 MC-0004 Discovery Kit containing DIs B493BRCS02, B493BRCD01, B493BRCP01, B493BRCP02, B49 Discovery Kit containing DIs B493BRCS02, B493BRCD01, B493BRCP01, B493BRCP02, B493BRCP03, B493BRCT01, B493BSPS01, B493BRCA05, B493MC0009 BioStamp nPoint™ MC10, INC.
17 B493MC0003 MC-0003 Exploratory Kit containing DIs B493BRCS02, B493BRCD01, B493BRCP01, B493BRCP02, B Exploratory Kit containing DIs B493BRCS02, B493BRCD01, B493BRCP01, B493BRCP02, B493BRCP03, B493BRCT01, B493BSPS01, B493BRCA05, B493MC0009 BioStamp nPoint™ MC10, INC.
18 B493BSPS01 BSPS01 Link Hub smart charger power supply BioStamp® MC10, INC.
19 B493BRCT01 BRCT01 Mobile application tablet BioStamp nPoint™ MC10, INC.
20 B493BRCS02 BRCS02 Wearable sensor patch BioStamp® MC10, INC.
21 B493BRCP03 BRCP03 Mobile application phone BioStamp® MC10, INC.
22 B493BRCP02 BRCP02 Mobile application phone BioStamp nPoint™ MC10, INC.
23 B493BRCP01 BRCP01 Mobile application phone BioStamp nPoint™ MC10, INC.
24 B493BRCD02 BRCD02 Link Hub smart charger BioStamp® MC10, INC.
25 B493BRCD01 BRCD01 Link Hub smart charger BioStamp nPoint™ MC10, INC.
26 B493BRCA05 BRCA05 Adhesive applicator BioStamp® MC10, INC.
27 B493BRCA02 BRCA02 Adhesive with hydrogel BioStamp® MC10, INC.
28 B3945700047020 miniCap Sidestream 570-0047-02 miniCap Sidestream WVSM Wireless Vital Signs Monitor ATHENA GTX, INC.
29 B3945700047010 miniCap Mainstream 570-0047-01 miniCap Mainstream WVSM Wireless Vital Signs Monitor ATHENA GTX, INC.
30 B3945700025050 BP Extension Hose-5 ft 570-0025-05 BP Extension Hose-5 ft WVSM Wireless Vital Signs Monitor ATHENA GTX, INC.
31 B3945700025040 BP Extension Hose-4 ft 570-0025-04 BP Extension Hose-4 ft WVSM Wireless Vital Signs Monitor ATHENA GTX, INC.
32 B3945700025030 BP Extension Hose-3 ft 570-0025-03 BP Extension Hose-3 ft WVSM Wireless Vital Signs Monitor ATHENA GTX, INC.
33 B3945700025020 BP Extension Hose-2 ft 570-0025-02 BP Extension Hose-2 ft WVSM Wireless Vital Signs Monitor ATHENA GTX, INC.
34 B3945700025010 BP Extension Hose 570-0025-01 BP Extension Hose-1 ft WVSM Wireless Vital Signs Monitor ATHENA GTX, INC.
35 B3945700024010 Shoulder Strap 570-0024-01 Shoulder Strap-Black WVSM Wireless Vital Signs Monitor ATHENA GTX, INC.
36 B3945700004020 ECG Cables 570-0004-02 ECG Lead Wires - Bonded WVSM Wireless Vital Signs Monitor ATHENA GTX, INC.
37 B3945700004010 ECG Cables 570-0004-01 ECG Lead Wires - Unbonded WVSM Wireless Vital Signs Monitor ATHENA GTX, INC.
38 B3945500039010 Data Cable 550-0039-01 USB Data Cable WVSM Wireless Vital Signs Monitor ATHENA GTX, INC.
39 B394530023020 WVSM Aux Battery (Angled) 530-0023-02 WVSM Aux Battery (Angled) WVSM Wireless Vital Signs Monitor ATHENA GTX, INC.
40 B3945300025010 Power Adapter 530-0025-01 AC/DC Power Supply WVSM Wireless Vital Signs Monitor ATHENA GTX, INC.
41 B3945300023010 WVSM Aux Battery (Straight) 530-0023-01 WVSM Aux Battery (Straight) WVSM Wireless Vital Signs Monitor ATHENA GTX, INC.
42 B3945300002010 Charger 530-0002-01 A/C Power Brick WVSM Wireless Vital Signs Monitor ATHENA GTX, INC.
43 B3945100004040 TACPAC 510-0004-04 Custom Pouch for 2 WVSMs WVSM Wireless Vital Signs Monitor ATHENA GTX, INC.
44 B3945100004030 Carry Case-10 WVSM 510-0004-03 Carry Case for 10 WVSMs WVSM Wireless Vital Signs Monitor ATHENA GTX, INC.
45 B3945100004020 Carry Case-4 WVSM 510-0004-02 Carry Case for 4 WVSMs WVSM Wireless Vital Signs Monitor ATHENA GTX, INC.
46 B3945100004010 Carry Case-2 WVSM 510-0004-01 Carry Case for 2 WVSMs WVSM Wireless Vital Signs Monitor ATHENA GTX, INC.
47 B3945000034040 WVSM RWC + miniCap 500-0034-04 Wireless Patient Monitor WVSM Wireless Vital Signs Monitor ATHENA GTX, INC.
48 B3945000034030 WVSM RWC + miniCap 500-0034-03 Wireless Patient Monitor WVSM Wireless Vital Signs Monitor ATHENA GTX, INC.
49 B3945000034020 WVSM RWC + miniCap 500-0034-02 Wireless Patient Monitor WVSM Wireless Vital Signs Monitor ATHENA GTX, INC.
50 B3945000034010 WVSM RWC + miniCap 500-0034-01 Wireless Patient Monitor WVSM Wireless Vital Signs Monitor ATHENA GTX, INC.