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 | B146ER9WES0 | 900-0581-55 | Wireless Arrhythmia Event Recorder | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | ER920W Empire Scanning | |
35 | B146ER9WCM0 | 900-0581-06 | Wireless Arrhythmia Event Recorder | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | ER920W Cardiomedix | |
36 | B146ER9WCL20 | 900-0581-35 | Wireless Arrhythmia Event Recorder | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | ER920W Cardiolabs | |
37 | B146ER9WB0 | 900-0581-00 | Wireless Arrhythmia Event Recorder | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | ER920W Braemar | |
38 | 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 |
39 | B146DL9BS0 | 900-0570-26 | Holter Recorder | MWJ | Electrocardiograph,Ambulatory(Without Analysis) | 2 | DL900 Base | |
40 | B146DL9BK0 | 900-0570-19 | Holter Recorder | MWJ | Electrocardiograph,Ambulatory(Without Analysis) | 2 | DL900 Burdick 4250 | |
41 | B146DL9AT0 | 900-0570-12 | Holter Recorder | MWJ | Electrocardiograph,Ambulatory(Without Analysis) | 2 | DL900 Amedtec SD | |
42 | B146DL8CN0 | 900-0543-15 | Holter Monitor | MWJ | Electrocardiograph,Ambulatory(Without Analysis) | 2 | DL800 CardioNet | |
43 | B146DL830 | 350-0235-03 | IKD | Cable, Electrode | 2 | DL800 Patient Cable | ||
44 | B146DL800 | 350-0235-00 | IKD | Cable, Electrode | 2 | DL800 Patient Cable | ||
45 | B146C6E10 | 02-01846 | DSI | Detector And Alarm, Arrhythmia | 2 | C6 Sensor 3.0 | ||
46 | B146C6D0 | 02-01561 | DSI | Detector And Alarm, Arrhythmia | 2 | C6 Sensor D | ||
47 | B146C5M0 | 100-0025-01 | Ambulatory ECG Monitoring system | DSI | Detector And Alarm, Arrhythmia | 2 | C5 Monitor | |
48 | B146BTPL210 | 02-01560 | DSI | Detector And Alarm, Arrhythmia | 2 | BTP-1000L-2 BTI | ||
49 | B146PERB0 | 900-0553-03 | ENHANCED ALGORITHM ECG EVENT RECORDER | MWJ | Electrocardiograph,Ambulatory(Without Analysis) | 2 | PER900 Braemar | |
50 | B146UNM0 | 900-0581-56 | Wireless Arrhythmia Event Recorder | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | ER920W UNM |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B635BIOTRES100 | 1.0 | Biotricity | BIOTRICITY INC | ||
2 | B632MDB01023 | HA3P | MDB01023 | Mediblu | MEDIBLU MEDICAL LLC | |
3 | B353MM12501 | MM1250 | Wearable Biosensor - ECG Remote Monitoring Biosensor Patch | MonitorMe | LIFESIGNALS, INC. | |
4 | B353MA12511 | MA1251 | MA1251_US | Wearable Biosensor - ECG Remote Monitoring Biosensor Patch | MAWI | LIFESIGNALS, INC. |
5 | B353LP12531 | LP1253 | LP1253_US | Wearable Biosensor - ECG Remote Monitoring Biosensor Patch | LifeSignals | LIFESIGNALS, INC. |
6 | B353LP12511 | LP1251 | LP1251_US | Wearable Biosensor - ECG Remote Monitoring Biosensor | LifeSignals | LIFESIGNALS, INC. |
7 | B353LP12501 | LP1250 | Wearable Biosensor - ECG Remote Monitoring Biosensor Patch | LifeSignals | LIFESIGNALS, INC. | |
8 | B353LA1252R1 | LA1252R | HOLTER CONNECT Relay Application is a software that is installed on a compatible HOLTER CONNECT Relay Application is a software that is installed on a compatible commercially available platform (mobile or tablet) that manages secured wireless communication between the Biosensor and the HOLTER CONNECT Secure Server for transferring acquired ECG data by the Biosensor. | HOLTER CONNECT | LIFESIGNALS, INC. | |
9 | B353LA1252C1 | LA1252C | HOLTER CONNECT business logic is a software running on cloud platform that provi HOLTER CONNECT business logic is a software running on cloud platform that provides interface for technician to generate Holter report on ECG data of patient, provides interface for physician to access and e-sign the Holter Report generated by the ECG technician. | HOLTER CONNECT | LIFESIGNALS, INC. | |
10 | B353CV12531 | CV1253 | CV1253_US | Wearable Biosensor - ECG Remote Monitoring Biosensor Patch | CorVitals | LIFESIGNALS, INC. |
11 | B353CV12451 | CV1245 | Biosensor Patch - Electrocardiography Telemetric Monitoring Patch | CORVITALS | LIFESIGNALS, INC. | |
12 | B353AB12571 | AB1257 | AB1257_US | Wearable Biosensor - ECG Remote Monitoring Biosensor | Advance Biometrix | LIFESIGNALS, INC. |
13 | B353AB12511 | AB1251 | AB1251_US | Wearable Biosensor - ECG Remote Monitoring Biosensor | Advance Biometrix | LIFESIGNALS, INC. |
14 | B329AWVC23 | Cardio | 08-603 | Ambulatory ECG recorder with accelerometer - single channel | Actiwave | CAMNTECH LIMITED |
15 | B329AWV04E22 | 4E | 08-557 | Ambulatory ECG/EEG recorder - four channel | Actiwave | CAMNTECH LIMITED |
16 | B329AWV02M25 | 2M | 08-536 | Ambulatory Electromyogram (EMG) - two channel | Actiwave | CAMNTECH LIMITED |
17 | B329AWV02E25 | 2E | 08-521 | Ambulatory ECG/EEG recorder - two channel | Actiwave | CAMNTECH LIMITED |
18 | B329AWV01E22 | 1E | 08-514 | Ambulatory ECG/EEG recorder - single channel | Actiwave | CAMNTECH LIMITED |
19 | B146PERP0 | 900-0553-06 | ENHANCED ALGORITHM ECG EVENT RECORDER | PER900 Preventice | BRAEMAR MANUFACTURING, LLC | |
20 | B146PERB0 | 900-0553-03 | ENHANCED ALGORITHM ECG EVENT RECORDER | PER900 Braemar | BRAEMAR MANUFACTURING, LLC | |
21 | B146ER9RAF0 | 900-0557-07 | ENHANCED ALGORITHM ECG EVENT RECORDER | ER920 Rozinn, AFIB | BRAEMAR MANUFACTURING, LLC | |
22 | B146ER9R0 | 900-0557-06 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& | ENHANCED ALGORITHM ECG EVENT RECORDER | ER920 Rozinn | BRAEMAR MANUFACTURING, LLC |
23 | B146ER9BAF0 | 900-0557-03 | ENHANCED ALGORITHM ECG EVENT RECORDER | ER920 Braemar, AFIB | BRAEMAR MANUFACTURING, LLC | |
24 | B146ER9B0 | 900-0557-01 | ENHANCED ALGORITHM ECG EVENT RECORDERhttps://gudid.fda.gov/gudid/app/admin/udi/r ENHANCED ALGORITHM ECG EVENT RECORDERhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1058652# | ER920 Braemar | BRAEMAR MANUFACTURING, LLC | |
25 | B146DL9ZW0 | 900-0570-25 | DL900 | BRAEMAR MANUFACTURING, LLC | ||
26 | B146DL9ST0 | 900-0570-27 | Holter Recorder | DL900 Standard | BRAEMAR MANUFACTURING, LLC | |
27 | B146DL9RA0 | 900-0570-14 | Holter Recorder | DL900 Remote Analysis | BRAEMAR MANUFACTURING, LLC | |
28 | B146DL9NV0 | 900-0570-15 | Holter Recorder | DL900 Norav 7 day CE | BRAEMAR MANUFACTURING, LLC | |
29 | B146DL9NE0 | 900-0570-24 | Holter Recorder | DL900 Norav Encrypted | BRAEMAR MANUFACTURING, LLC | |
30 | B146DL9FM0 | 900-0570-23 | Holter Recorder | DL900 Forest Medical | BRAEMAR MANUFACTURING, LLC | |
31 | B146DL9BS0 | 900-0570-26 | Holter Recorder | DL900 Base | BRAEMAR MANUFACTURING, LLC | |
32 | B146DL9BK0 | 900-0570-19 | Holter Recorder | DL900 Burdick 4250 | BRAEMAR MANUFACTURING, LLC | |
33 | B146DL9BD0 | 900-0570-20 | Holter Recorder | DL900 Biomedical SyS | BRAEMAR MANUFACTURING, LLC | |
34 | B146DL9B70 | 900-0570-16 | Holter Recorder | DL900 Braemar 7day | BRAEMAR MANUFACTURING, LLC | |
35 | B146DL9B0 | 900-0570-10 | Holter Recorder | DL900 Braemar SD | BRAEMAR MANUFACTURING, LLC | |
36 | B146DL9AT0 | 900-0570-12 | Holter Recorder | DL900 Amedtec SD | BRAEMAR MANUFACTURING, LLC | |
37 | B146DL95030 | 900-0616-03 | DL950 Braemar Standard | BRAEMAR MANUFACTURING, LLC | ||
38 | B146DL95020 | 900-0616-02 | DL950 Braemar Base | BRAEMAR MANUFACTURING, LLC | ||
39 | B146DL95010 | 900-0616-01 | DL950 Braemar | BRAEMAR MANUFACTURING, LLC | ||
40 | B146DL95000 | 900-0616-00 | DL950 Braemar | BRAEMAR MANUFACTURING, LLC | ||
41 | B146DL9280 | 900-0570-28 | DL900 | BRAEMAR MANUFACTURING, LLC | ||
42 | B146DL8NVE0 | 900-0543-21 | DL800 Holter recorder | DL800 Norav Encrypted | BRAEMAR MANUFACTURING, LLC | |
43 | B146DL8NV0 | 900-0543-20 | Holter Recorder | DL800 Norav | BRAEMAR MANUFACTURING, LLC | |
44 | B146DL8NO2560 | 900-0543-12 | Holter Monitor | DL800 Norav 256 s/s 8bit | BRAEMAR MANUFACTURING, LLC | |
45 | B146DL8FM0 | 900-0543-17 | Holter Recorder | DL800 Forest Medical 256 s/s 8 bit | BRAEMAR MANUFACTURING, LLC | |
46 | B146DL8CN0 | 900-0543-15 | Holter Monitor | DL800 CardioNet | BRAEMAR MANUFACTURING, LLC | |
47 | B146DL8CL0 | 900-0543-11 | Holter Recorder | DL800 CardioLabs | BRAEMAR MANUFACTURING, LLC | |
48 | B146DL8BD0 | 900-0543-19 | Holter Recorder | DL800 Biomedical SYS | BRAEMAR MANUFACTURING, LLC | |
49 | B146DL8B1330 | 900-0543-04 | Holter Recorder | DL800 Braemar 133 s/s | BRAEMAR MANUFACTURING, LLC | |
50 | B146DL8256B0 | 900-0543-09 | Holter Recorder | DL800 Braemar 256 s/s 10 bit | BRAEMAR MANUFACTURING, LLC |