No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00850490007306 | 8102-01 | 8102-01 | VistaTablet™ 2.0 (Boxed) | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | VistaTablet™ 2.0 (Boxed) |
2 | 00850490007214 | 3035-01 | 3035-01 | VitalPatch 2.0 Single | DRG,DSI,MHX | Transmitters And Receivers, Physiological Signal, Radiofrequency,Detector And Al Transmitters And Receivers, Physiological Signal, Radiofrequency,Detector And Alarm, Arrhythmia,Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | VitalPatch™ 2.0 Single | |
3 | 00850490007146 | 3012-01 | MHX,DSI,DRG | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms),Detector An Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms),Detector And Alarm, Arrhythmia,Transmitters And Receivers, Physiological Signal, Radiofrequency | VitalPatch® Active Biosensor | |||
4 | 00850490007047 | 1025-01 | MHX,DSI,DRG | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms),Detector An Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms),Detector And Alarm, Arrhythmia,Transmitters And Receivers, Physiological Signal, Radiofrequency | HealthPatch® MD Module | |||
5 | 00850490007450 | 4007-01 | 4007-01 | VitalPatch Biosensor | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | VitalPatch® RTM |
6 | 00850490007313 | 9510-01 | 9510-01 | Vista Solution® 2.0 10-day Evaluation Kit | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | Vista Solution® 2.0 10-day Evaluation Kit |
7 | 00850490007269 | 9410-01 | 9410-01 | Vista Solution® 10-day Evaluation Kit | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | Vista Solution® 10-day Evaluation Kit |
8 | 00850490007412 | 9610 | 9610 | Vista Solution 3 10-day Evaluation Kit | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | Vista Solution 3 10-day Evaluation Kit |
9 | 00850490007382 | 6100-03 | 6100-03 | User interface in the patient's room | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | VistaPoint Software User Interface |
10 | 00850490007177 | 8001-01 | 8001-01 | VistaHub-WiFi relay device to be used with the Vista Solution and VitalPatch biosensor. | MHX,DSI,DRG | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms),Detector An Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms),Detector And Alarm, Arrhythmia,Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | VistaHub-WiFi |
11 | 00850490007160 | 6100-01 | 6100-01 | User interface in the patient's room | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | VistaPoint Software User Interface |
12 | 00850490007009 | 1001-01 | MHX,DSI,DRG | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms),Detector An Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms),Detector And Alarm, Arrhythmia,Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | HealthPatch® MD Gentle Patch | ||
13 | 00850490007443 | 1400-02 | 1400-02 | VitalConnect 14-day Cardiac Monitoring Kit | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | VitalConnect 14-day Cardiac Monitoring Kit |
14 | 00850490007344 | 3037-01 | 3047-01 | VitalPatch 2.0, 7 days | DRG,DSI,MHX | Transmitters And Receivers, Physiological Signal, Radiofrequency,Detector And Al Transmitters And Receivers, Physiological Signal, Radiofrequency,Detector And Alarm, Arrhythmia,Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 | VitalPatch 2.0 |
15 | 00850490007375 | 6200-03 | 6200-03 | Multipatient user interface, convenience view of VistaPoint | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | VistaCenter |
16 | 00850490007139 | 6200-01 | 6200-01 | Multipatient user interface, convenience view of VistaPoint | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | VistaCenter |
17 | 00850490007016 | 1002-01 | MHX,DSI,DRG | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms),Detector An Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms),Detector And Alarm, Arrhythmia,Transmitters And Receivers, Physiological Signal, Radiofrequency | HealthPatch® MD Active Patch | |||
18 | 00850490007252 | 9430-01 | 9430-01 | Vista Solution® 30-day Monitoring Kit | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | Vista Solution® 30-day Monitoring Kit |
19 | 00850490007078 | 3002-01 | MHX,DSI,DRG | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms),Detector An Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms),Detector And Alarm, Arrhythmia,Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | "VitalPatch™ Active Patch | ||
20 | 00850490007054 | 3001-01 | MHX,DSI,DRG | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms),Detector An Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms),Detector And Alarm, Arrhythmia,Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | "VitalPatch™ Gentle Patch | ||
21 | 00850490007467 | 8303-02 | 8303-02 | Vista Phone A21 relay device | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | VistaPhone |
22 | 00850490007436 | 8303-01 | 8303-01 | Vista Phone relay device | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | VistaPhone |
23 | 00850490007429 | 8203-01 | 8203-01 | VistaTablet Relay Device | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | VistaTablet |
24 | 00850490007399 | 8103-01 | 8103-01 | Vista Tablet relay device | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | VistaTablet | |
25 | 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 | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | VistaTablet™ 2.0 RELAY (W/O VCI Box) |
26 | 00850490007283 | 3801-01 | 3801-01 | VitalPatch Adhesive Overlay | KGX | Tape And Bandage, Adhesive | 1 | VitalPatch Adhesive Overlay |
27 | 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 | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | VistaTablet |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B690MS10 | 1400 | MoMe® Software Platform is a web-based remote server software with proprietary a MoMe® Software Platform is a web-based remote server software with proprietary algorithms for analysis of ECG data. It analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review. The data is sent to the Software Platform from the MoMe® Kardia , a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring. | MoMe® Software Platform | INFOBIONIC, INC. | |
2 | B690MK10 | 01854 | MoMe® Kardia is a wireless, remote monitoring system designed to aid physicians MoMe® Kardia is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring. MoMe® Kardia includes the wearable device that acquires and stores ECG data and transmits that data via cellular technology to the MoMe® Software Platform, a web-based remote server software with proprietary algorithms for analysis. MoMe® Software Platform analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review. | MoMe® Kardia | INFOBIONIC, INC. | |
3 | B632MDB01037 | MM1 | MDB01037 | Mediblu | MEDIBLU MEDICAL LLC | |
4 | B632MDB01028 | BLU 12 | MDB01028 | Mediblu | MEDIBLU MEDICAL LLC | |
5 | B632MDB01007 | FM10 | MDB01007 | Mediblu | MEDIBLU MEDICAL LLC | |
6 | B632MDB01004 | MM5 | MDB01004 | Mediblu | MEDIBLU MEDICAL LLC | |
7 | B632MDB01003 | MM12 | MDB01003 | Mediblu | MEDIBLU MEDICAL LLC | |
8 | B632MDB01002 | MM15 | MDB01002 | Mediblu | MEDIBLU MEDICAL LLC | |
9 | B632MDB01001 | MM17 | MDB01001 | Mediblu | MEDIBLU MEDICAL LLC | |
10 | 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 |
11 | 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 |
12 | 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 |
13 | B510PM2000XLPRO1 | PM-2000XL PRO | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | ||
14 | B510PM2000XLPLUS1 | PM-2000XL PLUS | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | ||
15 | B510PM2000XL1 | PM-2000XL | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | ||
16 | B510PM2000TM1 | PM-2000TM | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | ||
17 | B510PM2000TM1 | PM-2000TM | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | ||
18 | B510PM2000M1 | PM-2000M | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | ||
19 | B510PM2000M1 | PM-2000M | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | ||
20 | B510PM2000APRO1 | PM-2000A PRO | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | ||
21 | B510PM2000APRO1 | PM-2000A PRO | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | ||
22 | B510PM2000A1 | PM-2000A | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | ||
23 | B510PM2000A1 | PM-2000A | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | ||
24 | B510CMS20001 | CMS-2000 | ADVANCED CENTRAL MONITORING STATION | ADVANCED INSTRUMENTATIONS, INC. | ||
25 | B493SW0028 | SW-0028 | Web application | BioStamp nPoint™ | MC10, INC. | |
26 | B493SW0027 | SW-0027 | Investigator application for Android | BioStamp nPoint™ | MC10, INC. | |
27 | B493SW0026 | SW-0027 | Sync application for Android | BioStamp nPoint™ | MC10, INC. | |
28 | B493SW0025 | SW-0025 | Link application for Android | BioStamp nPoint™ | MC10, INC. | |
29 | B493MC0015 | MC-0015 | MC-0015 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05 | BioStamp nPoint™ | MC10, INC. | |
30 | 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. | |
31 | B493MC0013 | MC-0013 | MC-0013 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05 | BioStamp nPoint™ | MC10, INC. | |
32 | B493MC0012 | MC-0012 | MC-0012 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05 | BioStamp nPoint™ | MC10, INC. | |
33 | B493MC0008 | MC-0008 | MC-0008 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05 | BioStamp nPoint™ | MC10, INC. | |
34 | 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. | |
35 | B493MC0006 | MC-0006 | MC-0006 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05 | BioStamp nPoint™ | MC10, INC. | |
36 | B493MC0005 | MC-0005 | MC-0005 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05 | BioStamp nPoint™ | MC10, INC. | |
37 | 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. | |
38 | 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. | |
39 | B493BSPS01 | BSPS01 | Link Hub smart charger power supply | BioStamp® | MC10, INC. | |
40 | B493BRCT01 | BRCT01 | Mobile application tablet | BioStamp nPoint™ | MC10, INC. | |
41 | B493BRCS02 | BRCS02 | Wearable sensor patch | BioStamp® | MC10, INC. | |
42 | B493BRCP03 | BRCP03 | Mobile application phone | BioStamp® | MC10, INC. | |
43 | B493BRCP02 | BRCP02 | Mobile application phone | BioStamp nPoint™ | MC10, INC. | |
44 | B493BRCP01 | BRCP01 | Mobile application phone | BioStamp nPoint™ | MC10, INC. | |
45 | B493BRCD02 | BRCD02 | Link Hub smart charger | BioStamp® | MC10, INC. | |
46 | B493BRCD01 | BRCD01 | Link Hub smart charger | BioStamp nPoint™ | MC10, INC. | |
47 | B493BRCA05 | BRCA05 | Adhesive applicator | BioStamp® | MC10, INC. | |
48 | B493BRCA02 | BRCA02 | Adhesive with hydrogel | BioStamp® | MC10, INC. | |
49 | B485CNSVID3701 | CNS-VID-370 | International model; optional camera that can be used to record video of the patient. | Component Monitoring System | MOBERG RESEARCH INC | |
50 | B485CNSVID3501 | CNS-VID-350 | Optional camera that can be used to record video of the patient. | Component Monitoring System | MOBERG RESEARCH INC |