No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | B353MA12511 | MA1251 | MA1251_US | Wearable Biosensor - ECG Remote Monitoring Biosensor Patch | DRG,MWJ | Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiogr Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiograph, Ambulatory (Without Analysis) | MAWI | |
2 | B353CV12531 | CV1253 | CV1253_US | Wearable Biosensor - ECG Remote Monitoring Biosensor Patch | DRG,MWJ,MHX | Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiogr Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiograph, Ambulatory (Without Analysis),Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | CorVitals | |
3 | B353LP12531 | LP1253 | LP1253_US | Wearable Biosensor - ECG Remote Monitoring Biosensor Patch | DRG,MWJ,MHX | Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiogr Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiograph, Ambulatory (Without Analysis),Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | LifeSignals | |
4 | B353LP12511 | LP1251 | LP1251_US | Wearable Biosensor - ECG Remote Monitoring Biosensor | DRG,MWJ | Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiogr Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiograph, Ambulatory (Without Analysis) | 2 | LifeSignals |
5 | B353AB12571 | AB1257 | AB1257_US | Wearable Biosensor - ECG Remote Monitoring Biosensor | DRG,MWJ | Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiogr Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiograph, Ambulatory (Without Analysis) | Advance Biometrix | |
6 | B353AB12511 | AB1251 | AB1251_US | Wearable Biosensor - ECG Remote Monitoring Biosensor | DRG,MWJ | Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiogr Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiograph, Ambulatory (Without Analysis) | Advance Biometrix | |
7 | B353IM11101 | IM1110 | Biosensor Patch - Electrocardiography Telemetric Monitoring Patch | DRG,DRX,DRT | Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrode, Elec Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrode, Electrocardiograph,Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 2 | ImagineMIC | |
8 | B353MM12501 | MM1250 | Wearable Biosensor - ECG Remote Monitoring Biosensor Patch | DRG,MWJ | Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiogr Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiograph, Ambulatory (Without Analysis) | MonitorMe | ||
9 | B353LP11101 | LP1110 | Biosensor Patch - Electrocardiography Telemetric Monitoring Patch | DRT,DRG,DRX | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm),Transmitters And Receiver Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm),Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrode, Electrocardiograph | 2 | LifeSignal | |
10 | 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. | DRG,MWJ | Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiogr Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiograph, Ambulatory (Without Analysis) | 2 | HOLTER CONNECT | |
11 | 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. | DRG,MWJ | Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiogr Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrocardiograph, Ambulatory (Without Analysis) | 2 | HOLTER CONNECT | |
12 | B353IM12101 | IM1210 | Biosensor Patch - Electrocardiography Telemetric Monitoring Patch | DRG,DRX,DRT | Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrode, Elec Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrode, Electrocardiograph,Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 2 | ImagineMed | |
13 | B353CV12451 | CV1245 | Biosensor Patch - Electrocardiography Telemetric Monitoring Patch | MWJ,DRG | Electrocardiograph, Ambulatory (Without Analysis),Transmitters And Receivers, Ph Electrocardiograph, Ambulatory (Without Analysis),Transmitters And Receivers, Physiological Signal, Radiofrequency | CORVITALS | ||
14 | B353CS124501 | CS1245 | Biosensor Patch - Electrocardiography Telemetric Monitoring Patch | DRT,DRG,DRX | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm),Transmitters And Receiver Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm),Transmitters And Receivers, Physiological Signal, Radiofrequency,Electrode, Electrocardiograph | Cherish Serenity |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 08056732654594 | HD+ | 81018027 | Digital portable acquisition device which can acquire the electrocardiographic s Digital portable acquisition device which can acquire the electrocardiographic signal of 12 standard leads. Connected with a receiver via Bluetooth, sends the data to the host. | HD+ | CARDIOLINE SPA |
2 | 08031527016023 | 7 leads | SPIDERVIEW | MICROPORT CRM SRL | ||
3 | 08031527015149 | Pouch | SPIDERVIEW | MICROPORT CRM SRL | ||
4 | 08031527015132 | SPIDERVIEW | CUSTODIA | MICROPORT CRM SRL | ||
5 | 08031527015095 | 3 Leads XYZ / 7E | SPIDERVIEW | MICROPORT CRM SRL | ||
6 | 08031527015088 | 2 Leads / 5 E | SPIDERVIEW | MICROPORT CRM SRL | ||
7 | 08031527015071 | 12 Leads / 10 E | SPIDERVIEW | MICROPORT CRM SRL | ||
8 | 08031527015064 | XYZ-HR / 7E | SPIDERVIEW | MICROPORT CRM SRL | ||
9 | 08031527015057 | 2 Leads / 3E | SPIDERVIEW / SPIDERFLASH | MICROPORT CRM SRL | ||
10 | 08031527014890 | PLUS | SPIDERVIEW | MICROPORT CRM SRL | ||
11 | 08031527014883 | SD Card | SPIDERVIEW+ SD MEMORY CARD | MICROPORT CRM SRL | ||
12 | 08031527014876 | SPIDERVIEW | SPIDERVIEW | MICROPORT CRM SRL | ||
13 | 08031527013428 | SD Card | SPIDERVIEW & SPIDERFLASH-T MEMORY CARD | MICROPORT CRM SRL | ||
14 | 08031527013411 | SD card | SPIDERVIEW SD MEMORY CARD | MICROPORT CRM SRL | ||
15 | 08031527013398 | SPIDERVIEW | SPIDERVIEW | MICROPORT CRM SRL | ||
16 | 07290110255404 | NR1207-E Kit | NR1207E-K-00-E-B10-06 | Kit includes: Norav Wireless ECG Acquisition Device NR3 (UDI: 7290110255381) for Kit includes: Norav Wireless ECG Acquisition Device NR3 (UDI: 7290110255381) for Resting-ECG with IEC type labelling. Input cable with 10 Patient leads IEC type and Banana connectors. | Norav NR Series | NORAV MEDICAL LTD. |
17 | 07290110255381 | NR1207-E | NR1207E-D-00E-06 | Norav Wireless ECG Acquisition Device NR3 for Resting-ECG with IEC type labelling. | Norav NR Series | NORAV MEDICAL LTD. |
18 | 07290110255374 | NR1207-3 | NR12073-D-00E-06 | Norav Wireless 3In1 Acquisition Device NR3 for Resting-ECG combined with Respira Norav Wireless 3In1 Acquisition Device NR3 for Resting-ECG combined with Respiration and Body-Movement - IEC type labelling. | Norav NR Series | NORAV MEDICAL LTD. |
19 | 07290110255343 | NR1207-3 Kit | NR12073-K-00-E-02 | Kit includes: Norav Wireless 3In1 Acquisition Device NR2 (UDI: 7290110254872) fo Kit includes: Norav Wireless 3In1 Acquisition Device NR2 (UDI: 7290110254872) for Resting-ECG combined with Respiration and Body-Movement - IEC type labelling.Special edition for TASHIO | Norav NR Series | NORAV MEDICAL LTD. |
20 | 07290110255213 | NR1207-3 Kit | NR12073-K-00-E-01 | Kit includes: Norav Wireless 3In1 Acquisition Device NR1 (UDI: 7290110253134) fo Kit includes: Norav Wireless 3In1 Acquisition Device NR1 (UDI: 7290110253134) for Resting-ECG combined with Respiration and Body-Movement - IEC type labelling.Special edition for TASHIO | Norav NR Series | NORAV MEDICAL LTD. |
21 | 07290110255206 | NR1207-E Kit | NR1207E-K-00-E-01 | Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110253097) for Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110253097) for Resting-ECG with IEC type labelling.Special edition for TASHIO | Norav NR Series | NORAV MEDICAL LTD. |
22 | 07290110254919 | NR1207-3 Kit | NR12073-K-00-UB10S5-01 | Kit includes: Norav Wireless 3In1 Acquisition Device NR1 (UDI: 7290110254889) fo Kit includes: Norav Wireless 3In1 Acquisition Device NR1 (UDI: 7290110254889) for Resting-ECG combined with Respiration and Body-Movement - AHA type labelling. Input cable with 10 Patient leads AHA type and Banana connectors. Input cable with 5 Patient leads AHA type and Snap connectors. | Norav NR Series | NORAV MEDICAL LTD. |
23 | 07290110254902 | NR1207-3 Kit | NR12073-K-00-EB10S5-02 | Kit includes: Norav Wireless 3In1 Acquisition Device NR2 (UDI: 7290110254872) fo Kit includes: Norav Wireless 3In1 Acquisition Device NR2 (UDI: 7290110254872) for Resting-ECG combined with Respiration and Body-Movement - IEC type labelling. Input cable with 10 Patient leads IEC type and Banana connectors. Input cable with 5 Patient leads IEC type and Snap connectors. | Norav NR Series | NORAV MEDICAL LTD. |
24 | 07290110254896 | NR1207-3 | NR12073-D-00U-02 | Norav Wireless 3In1 Acquisition Device NR2 for Resting-ECG combined with Respira Norav Wireless 3In1 Acquisition Device NR2 for Resting-ECG combined with Respiration and Body-Movement - AHA type labelling. | Norav NR Series | NORAV MEDICAL LTD. |
25 | 07290110254889 | NR1207-3 | NR12073-D-00U-01 | Norav Wireless 3In1 Acquisition Device NR1 for Resting-ECG combined with Respira Norav Wireless 3In1 Acquisition Device NR1 for Resting-ECG combined with Respiration and Body-Movement - AHA type labelling. | Norav NR Series | NORAV MEDICAL LTD. |
26 | 07290110254872 | NR1207-3 | NR12073-D-00E-02 | Norav Wireless 3In1 Acquisition Device NR2 for Resting-ECG combined with Respira Norav Wireless 3In1 Acquisition Device NR2 for Resting-ECG combined with Respiration and Body-Movement - IEC type labelling. | Norav NR Series | NORAV MEDICAL LTD. |
27 | 07290110254834 | NR1207-E Kit | NR1207E-K-00-U-B10-02 | Kit includes: Norav Wireless ECG Acquisition Device NR2 (UDI: 7290110254773) for Kit includes: Norav Wireless ECG Acquisition Device NR2 (UDI: 7290110254773) for Resting-ECG with AHA type labelling. Input cable with 10 Patient leads AHA type and Banana connectors. | Norav NR Series | NORAV MEDICAL LTD. |
28 | 07290110254827 | NR1207-E Kit | NR1207E-K-00-U-B10-01 | Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110254766) for Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110254766) for Resting-ECG with AHA type labelling. Input cable with 10 Patient leads AHA type and Banana connectors. | Norav NR Series | NORAV MEDICAL LTD. |
29 | 07290110254810 | NR1207-E Kit | NR1207E-K-00-E-S10-01 | Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110253097) for Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110253097) for Resting-ECG with IEC type labelling. Input cable with 10 Patient leads IEC type and Snap connectors. | Norav NR Series | NORAV MEDICAL LTD. |
30 | 07290110254780 | NR1207-E Kit | NR1207E-K-00-E-B10-02 | Kit includes: Norav Wireless ECG Acquisition Device NR2 (UDI: 7290110254759) for Kit includes: Norav Wireless ECG Acquisition Device NR2 (UDI: 7290110254759) for Resting-ECG with IEC type labelling. Input cable with 10 Patient leads IEC type and Banana connectors. | Norav NR Series | NORAV MEDICAL LTD. |
31 | 07290110254773 | NR1207-E | NR1207E-D-00U-02 | Norav Wireless ECG Acquisition Device NR2 for Resting-ECG with AHA type labelling. | Norav NR Series | NORAV MEDICAL LTD. |
32 | 07290110254766 | NR1207-E | NR1207E-D-00U-01 | Norav Wireless ECG Acquisition Device NR1 for Resting-ECG with AHA type labelling. | Norav NR Series | NORAV MEDICAL LTD. |
33 | 07290110254759 | NR1207-E | NR1207E-D-00E-02 | Norav Wireless ECG Acquisition Device NR2 for Resting-ECG with IEC type labelling. | Norav NR Series | NORAV MEDICAL LTD. |
34 | 07290110254742 | NR1207 Kit | NR1207-K-00-U-S10-02 | Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 7290110254711) for A Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 7290110254711) for Ambulatory ECG Monitoring (Holter-ECG), 12ch., max. 7days and AHA type labelling; Input cable with 10 Patient leads AHA type and Snap connectors. | Norav NR Series | NORAV MEDICAL LTD. |
35 | 07290110254728 | NR1207 Kit | NR1207-K-00-E-S10-02 | Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 7290110254698) for A Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 7290110254698) for Ambulatory ECG Monitoring (Holter-ECG), 12ch., max. 7days and IEC type labelling; Input cable with 10 Patient leads IEC type and Snap connectors. | Norav NR Series | NORAV MEDICAL LTD. |
36 | 07290110254711 | NR1207 | NR1207-D-00U-02 | Norav Ambulatory ECG Recording Device NR2 for Ambulatory ECG Monitoring (Holter- Norav Ambulatory ECG Recording Device NR2 for Ambulatory ECG Monitoring (Holter-ECG) for maximum 7 days, with 12 channels, AHA type labelling. | Norav NR Series | NORAV MEDICAL LTD. |
37 | 07290110254704 | NR1207 | NR1207-D-00U-01 | Norav Ambulatory ECG Recording Device NR1 for Ambulatory ECG Monitoring (Holter- Norav Ambulatory ECG Recording Device NR1 for Ambulatory ECG Monitoring (Holter-ECG) for maximum 7 days, with 12 channels, AHA type labelling. | Norav NR Series | NORAV MEDICAL LTD. |
38 | 07290110254698 | NR1207 | NR1207-D-00E-02 | Norav Ambulatory ECG Recording Device NR2 for Ambulatory ECG Monitoring (Holter- Norav Ambulatory ECG Recording Device NR2 for Ambulatory ECG Monitoring (Holter-ECG) for maximum 7 days, with 12 channels, IEC type labelling. | Norav NR Series | NORAV MEDICAL LTD. |
39 | 07290110254681 | NR314T Kit | NR314T-K-00-U-S5-01 | Kit includes: Norav Telemetry ECG Acquisition Device NR1 (UDI: 07290110253332) Kit includes: Norav Telemetry ECG Acquisition Device NR1 (UDI: 07290110253332) for Telemetry Resting-ECG Monitoring with AHA type labelling; Input cable with 5 Patient leads, AHA type labelling. | Norav NR Series | NORAV MEDICAL LTD. |
40 | 07290110254636 | NR314T | NR314T-D-00U-02 | Norav Telemetry ECG Acquisition Device NR2 for Telemetry Resting-ECG Monitoring Norav Telemetry ECG Acquisition Device NR2 for Telemetry Resting-ECG Monitoring with AHA type labelling. | Norav NR Series | NORAV MEDICAL LTD. |
41 | 07290110254629 | NR314T | NR314T-D-00U-01 | Norav Telemetry ECG Acquisition Device NR1 for Telemetry Resting-ECG Monitoring Norav Telemetry ECG Acquisition Device NR1 for Telemetry Resting-ECG Monitoring with AHA type labelling. | Norav NR Series | NORAV MEDICAL LTD. |
42 | 07290110254612 | NR314T | NR314T-D-00E-02 | Norav Telemetry ECG Acquisition Device NR2 for Telemetry Resting-ECG Monitoring Norav Telemetry ECG Acquisition Device NR2 for Telemetry Resting-ECG Monitoring with IEC type labelling. | Norav NR Series | NORAV MEDICAL LTD. |
43 | 07290110254605 | NR314 Kit | NR314-K-00-U-S7-02 | Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254537) for Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254537) for Ambulatory ECG Monitoring (Holter-ECG), 3 ch., max. 14 days and AHA type labelling; Input cable with 7 Patient leads AHA type and Snap connectors. | Norav NR Series | NORAV MEDICAL LTD. |
44 | 07290110254582 | NR314 Kit | NR314-K-00-U-S5-02 | Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254537) for Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254537) for Ambulatory ECG Monitoring (Holter-ECG), 3 ch., max. 14 days and AHA type labelling; Input cable with 5 Patient leads AHA type and Snap connectors. | Norav NR Series | NORAV MEDICAL LTD. |
45 | 07290110254575 | NR314 Kit | NR314-K-00-U-S5-01 | Kit includes: Norav Ambulatory ECG Recording Unit NR1 (UDI: 07290110254520) for Kit includes: Norav Ambulatory ECG Recording Unit NR1 (UDI: 07290110254520) for Ambulatory ECG Monitoring (Holter-ECG), 3 ch., max. 14 days and AHA type labelling; Input cable with 5 Patient leads AHA type and Snap connectors. | Norav NR Series | NORAV MEDICAL LTD. |
46 | 07290110254568 | NR314 Kit | NR314-K-00-U-S3-02 | Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254537) for Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254537) for Ambulatory ECG Monitoring (Holter-ECG), 3 ch., max. 14 days and AHA type labelling; Input cable with 3 Patient leads AHA type and Snap connectors. | Norav NR Series | NORAV MEDICAL LTD. |
47 | 07290110254551 | NR314 Kit | NR314-K-00-U-S3-01 | Kit includes: Norav Ambulatory ECG Recording Unit NR1 (UDI: 07290110254520) for Kit includes: Norav Ambulatory ECG Recording Unit NR1 (UDI: 07290110254520) for Ambulatory ECG Monitoring (Holter-ECG), 3 ch., max. 14 days and AHA type labelling; Input cable with 3 Patient leads AHA type and Snap connectors. | Norav NR Series | NORAV MEDICAL LTD. |
48 | 07290110254544 | NR314 Kit | NR314-K-00-E-S7-02 | Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254513) for Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254513) for Ambulatory ECG Monitoring (Holter-ECG), 3 ch., max. 14 days and IEC type labelling; Input cable with 7 Patient leads IEC type and Snap connectors. | Norav NR Series | NORAV MEDICAL LTD. |
49 | 07290110254537 | NR314 | NR314-D-00U-02 | Norav Ambulatory ECG Recording Unit NR2 for Ambulatory ECG Monitoring (Holter-EC Norav Ambulatory ECG Recording Unit NR2 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channels, max. 14 days recording capacity and AHA type labelling. | Norav NR Series | NORAV MEDICAL LTD. |
50 | 07290110254520 | NR314 | NR314-D-00U-01 | Norav Ambulatory ECG Recording Unit NR1 for Ambulatory ECG Monitoring (Holter-EC Norav Ambulatory ECG Recording Unit NR1 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channels, max. 14 days recording capacity and AHA type labelling. | Norav NR Series | NORAV MEDICAL LTD. |