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 | 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 |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00852132007316 | SW1004 | Upload and transmission software application | PatientCare Link | PREVENTICE TECHNOLOGIES, INC. | |
2 | 00852132007309 | SW1003 | Monitor communication software application | ECG Plug-In | PREVENTICE TECHNOLOGIES, INC. | |
3 | 00852132007293 | SW1002 | Transmission software application | BodyGuardian Connect | PREVENTICE TECHNOLOGIES, INC. | |
4 | 00852132007286 | SW1001 | Platform software application for data collection and analysis | PatientCare Platform | PREVENTICE TECHNOLOGIES, INC. | |
5 | 00852132007248 | BG3003 | BodyGuardian One FBS Remote Monitoring System | BodyGuardian One | PREVENTICE TECHNOLOGIES, INC. | |
6 | 00852132007224 | BG2104 | BodyGuardian Mini Plus Monitoring System Kit for FBS customers | BodyGuardian Mini Plus Monitoring System Kit | PREVENTICE TECHNOLOGIES, INC. | |
7 | 00852132007217 | BG2004 | BodyGuardian Mini Monitoring System Kit - holter for FBS customers | BodyGuardian Mini Monitoring System Kit | PREVENTICE TECHNOLOGIES, INC. | |
8 | 00852132007200 | EUBG2003 | BodyGuardian Mini Procedure Pack | BodyGuardian | PREVENTICE TECHNOLOGIES, INC. | |
9 | 00852132007156 | EUBG2102 | BodyGuardian Mini Plus Procedure Pack | BodyGuardian | PREVENTICE TECHNOLOGIES, INC. | |
10 | 00852132007149 | BG2102 | BodyGuardian Mini Plus Remote Monitoring System Kit | BodyGuardian | PREVENTICE TECHNOLOGIES, INC. | |
11 | 00852132007132 | EUBG2002 | BodyGuardian Mini Holter Monitoring System kit | BodyGuardian | PREVENTICE TECHNOLOGIES, INC. | |
12 | 00852132007125 | BG2002 | BodyGuardian Mini Holter Monitoring System Kit | BodyGuardian | PREVENTICE TECHNOLOGIES, INC. | |
13 | 00852132007118 | EUBG2012 | BodyGuardian Mini Biobank kit | BodyGuardian | PREVENTICE TECHNOLOGIES, INC. | |
14 | 00852132007095 | BG1001MAZ | Remote Monitoring System Kit | BodyGuardian | PREVENTICE TECHNOLOGIES, INC. | |
15 | 00852132007057 | BG1001MAS | Remote Monitoring System Kit | BodyGuardian | PREVENTICE TECHNOLOGIES, INC. | |
16 | 00852132007019 | EUBG1001 | Remote Monitoring System Kit - Intl | BodyGuardian | PREVENTICE TECHNOLOGIES, INC. | |
17 | 00852132007002 | BG1001 | Remote Monitoring System Kit | BodyGuardian | PREVENTICE TECHNOLOGIES, INC. | |
18 | 00850733007414 | ViSi Emergency Medical Surveillance (EMS) Kit | 97-10259 | ViSi Emergency Medical Surveillance (EMS) Kit | ViSi | SOTERA WIRELESS, INC. |
19 | 00850725007101 | MCT 3L-International | 3 Lead Continuous ECG Monitor & Arrhythmia Detector (MCT 3L - International) | LifeWatch Mobile Cardiac Telemetry 3-Lead | LIFEWATCH | |
20 | 00850725007095 | MCT 3L-ES400-ATT | 3 Lead Continuous ECG Monitor & Arrhythmia Detector (ES400/Windows/ATT) | LifeWatch Mobile Cardiac Telemetry 3-Lead | LIFEWATCH | |
21 | 00850725007040 | MCT 1L Patch-Universal Gateway-Verizon | ECG Mini System Continuous ECG Monitor & Arrhythmia Detector (Universal Gateway/ ECG Mini System Continuous ECG Monitor & Arrhythmia Detector (Universal Gateway/Android/Verizon) | LifeWatch Mobile Cardiac Telemetry 1 Lead Patch | LIFEWATCH | |
22 | 00850725007033 | MCT 3L-Universal Gateway-Verizon | 3 Lead Continuous ECG Monitor & Arrhythmia Detector (Universal Gateway/Android/Verizon) | LifeWatch Mobile Cardiac Telemetry 3-Lead | LIFEWATCH | |
23 | 00850725007026 | MCT 3L-Brigadier-Verizon | 3 Lead Continuous ECG Monitor & Arrhythmia Detector (Brigadier/Android/Verizon) | LifeWatch Mobile Cardiac Telemetry 3-Lead | LIFEWATCH | |
24 | 00850725007019 | MCT 3L-ES400-Verizon | 3 Lead Continuous ECG Monitor & Arrhythmia Detector (ES400/Windows/Verizon) | LifeWatch Mobile Cardiac Telemetry 3-Lead | LIFEWATCH | |
25 | 00850725007002 | MCT 3L- Ozone-Verizon | 3 Lead Continuous ECG Monitor & Arrhythmia Detector (Ozone/Windows/Verizon) | LifeWatch Mobile Cardiac Telemetry 3-Lead | LIFEWATCH | |
26 | 00850490007344 | 3037-01 | 3047-01 | VitalPatch 2.0, 7 days | VitalPatch 2.0 | VITAL CONNECT, INC. |
27 | 00850490007238 | 3037-01 | 3037-01 | VitalPatch 2.0, 7 days | VitalPatch 2.0 | VITAL CONNECT, INC. |
28 | 00850490007214 | 3035-01 | 3035-01 | VitalPatch 2.0 Single | VitalPatch™ 2.0 Single | VITAL CONNECT, INC. |
29 | 00850490007177 | 8001-01 | 8001-01 | VistaHub-WiFi relay device to be used with the Vista Solution and VitalPatch biosensor. | VistaHub-WiFi | VITAL CONNECT, INC. |
30 | 00850490007146 | 3012-01 | VitalPatch® Active Biosensor | VITAL CONNECT, INC. | ||
31 | 00850490007078 | 3002-01 | "VitalPatch™ Active Patch | VITAL CONNECT, INC. | ||
32 | 00850490007054 | 3001-01 | "VitalPatch™ Gentle Patch | VITAL CONNECT, INC. | ||
33 | 00850490007047 | 1025-01 | HealthPatch® MD Module | VITAL CONNECT, INC. | ||
34 | 00850490007016 | 1002-01 | HealthPatch® MD Active Patch | VITAL CONNECT, INC. | ||
35 | 00850490007009 | 1001-01 | HealthPatch® MD Gentle Patch | VITAL CONNECT, INC. | ||
36 | 00840682147224 | B125P VSP3.0 Patient Monitor | 6160000-002 | B125P ATO MODEL | NA | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
37 | 00840682147217 | B105P VSP3.0 Patient Monitor | 6160000-001 | B105P ATO MODEL | NA | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
38 | 00840682146791 | B155 VSP3.0 Patient Monitor | 6160000-005 | B155M ATO MODEL | NA | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
39 | 00840682146715 | B125 VSP3.0 Patient Monitor | 6160000-004 | B125M ATO MODEL | NA | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
40 | 00840682146708 | B105 VSP3.0 Patient Monitor | 6160000-003 | B105M ATO MODEL | NA | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
41 | 00840682146142 | MBC323 | 5805690 | CARESCAPE B850 MBC323 (ATO MODEL) | CARESCAPE B850 | GE HEALTHCARE FINLAND OY |
42 | 00840682146135 | MBA323 | 5805686 | CARESCAPE B450 MBA323 (ATO MODEL) | CARESCAPE B450 | GE HEALTHCARE FINLAND OY |
43 | 00840682146111 | MBB323 | 5805688 | CARESCAPE B650 MBB323 (ATO MODEL) | CARESCAPE B650 | GE HEALTHCARE FINLAND OY |
44 | 00840682144308 | MBC313 | CARESCAPE B850 MBC313 (ATO MODEL) | CARESCAPE B850 | GE HEALTHCARE FINLAND OY | |
45 | 00840682143806 | MBB313 | CARESCAPE B650 MBB313 (ATO MODEL) | CARESCAPE B650 | GE HEALTHCARE FINLAND OY | |
46 | 00840682142380 | MBA313 | CARESCAPE B450 MBA313 | CARESCAPE B450 | GE HEALTHCARE FINLAND OY | |
47 | 00840682141291 | V1.5 | B125/B105 V1.5 SW PACK (USB) - MD | B1X5 Software Upgrade | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | |
48 | 00840682138581 | B125 Patient Monitor | B125 V1.5 PATIENT MONITOR ATO MODEL | NA | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | |
49 | 00840682138574 | B105 Patient Monitor | 2099000-003 | B105 V1.5 PATIENT MONITOR ATO MODEL | NA | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
50 | 00840682123433 | MBRA001 | CARESCAPE RAD | GE HEALTHCARE FINLAND OY |