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 | B146DL9BD0 | 900-0570-20 | Holter Recorder | MWJ | Electrocardiograph,Ambulatory(Without Analysis) | 2 | DL900 Biomedical SyS | |
25 | B146DL95000 | 900-0616-00 | MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 2 | DL950 Braemar | ||
26 | B146DL9280 | 900-0570-28 | MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 2 | DL900 | ||
27 | B146DL900 | 350-0290-00 | IKD | Cable, Electrode | 2 | DL900 Patient cable | ||
28 | B146CK0 | 100-0030-01 | Holter Recorder | MWJ | Electrocardiograph,Ambulatory(Without Analysis) | 2 | Cardiokey | |
29 | 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 | ||
30 | B146M10 | 100-0046-02 | DSI | Detector And Alarm, Arrhythmia | 2 | C6 monitor | ||
31 | 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 | ||
32 | B146ERW3G040 | 900-0614-04 | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | ER9W 3GSM AMI | ||
33 | B146ER9WES0 | 900-0581-55 | Wireless Arrhythmia Event Recorder | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | ER920W Empire Scanning | |
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 |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | M581NEMK960 | DR200 7L | NEMK96 | DR200 holter recorder w/ 7L patient cable | DR200 | NORTHEAST MONITORING, INC. |
2 | M581NEMK950 | DR200 5L | NEMK95 | DR200 holter recorder w/ 5L patient cable | DR200 | NORTHEAST MONITORING, INC. |
3 | M581NEMK940 | DR200 2L | NEMK94 | DR200 holter recorder w/ 2L patient cable | DR200 | NORTHEAST MONITORING, INC. |
4 | M581NEMK1950 | LX Event Tool | NEMK195 | LX Event Tool (TelePro) | LX Event | NORTHEAST MONITORING, INC. |
5 | M581NEMK1570 | DR400 | NEMK157 | DR400 holter recorder with NEMEL002/003 patches | DR400 | NORTHEAST MONITORING, INC. |
6 | M581NEMK1560 | Gateway | NEMK156 | Gateway NEMK156 | Gateway | NORTHEAST MONITORING, INC. |
7 | M581NEMK1550 | DR300 7L | NEMK155 | DR300 | NORTHEAST MONITORING, INC. | |
8 | M581NEMK1540 | DR300 5L | NEMK154 | DR300 holter recorder w/ 5L patient cable | DR300 | NORTHEAST MONITORING, INC. |
9 | M581NEMK1400 | DR181 12L | DR181 holter recorder w/ 10L patient cable | DR181 | NORTHEAST MONITORING, INC. | |
10 | M581NEMK1390 | DR181 7L | NEMK139 | DR181 holter recorder w/ 7L patient cable | DR181 | NORTHEAST MONITORING, INC. |
11 | M581NEMK1380 | DR181 5L | NEMK138 | DR181 holter recorder w/ 5L patient cable | DR181 | NORTHEAST MONITORING, INC. |
12 | M581NEMK1290 | DR200 3L | NEMK129 | DR200 holter recorder w/ 3L patient cable | DR200 | NORTHEAST MONITORING, INC. |
13 | 08031527016023 | 7 leads | SPIDERVIEW | MICROPORT CRM SRL | ||
14 | 08031527015149 | Pouch | SPIDERVIEW | MICROPORT CRM SRL | ||
15 | 08031527015132 | SPIDERVIEW | CUSTODIA | MICROPORT CRM SRL | ||
16 | 08031527015095 | 3 Leads XYZ / 7E | SPIDERVIEW | MICROPORT CRM SRL | ||
17 | 08031527015088 | 2 Leads / 5 E | SPIDERVIEW | MICROPORT CRM SRL | ||
18 | 08031527015071 | 12 Leads / 10 E | SPIDERVIEW | MICROPORT CRM SRL | ||
19 | 08031527015064 | XYZ-HR / 7E | SPIDERVIEW | MICROPORT CRM SRL | ||
20 | 08031527015057 | 2 Leads / 3E | SPIDERVIEW / SPIDERFLASH | MICROPORT CRM SRL | ||
21 | 08031527014890 | PLUS | SPIDERVIEW | MICROPORT CRM SRL | ||
22 | 08031527014883 | SD Card | SPIDERVIEW+ SD MEMORY CARD | MICROPORT CRM SRL | ||
23 | 08031527014876 | SPIDERVIEW | SPIDERVIEW | MICROPORT CRM SRL | ||
24 | 08031527013428 | SD Card | SPIDERVIEW & SPIDERFLASH-T MEMORY CARD | MICROPORT CRM SRL | ||
25 | 08031527013411 | SD card | SPIDERVIEW SD MEMORY CARD | MICROPORT CRM SRL | ||
26 | 08031527013398 | SPIDERVIEW | SPIDERVIEW | MICROPORT CRM SRL | ||
27 | 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. |
28 | 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. |
29 | 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. |
30 | 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. |
31 | 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. |
32 | 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. |
33 | 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. |
34 | 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. |
35 | 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. |
36 | 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. |
37 | 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. |
38 | 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. |
39 | 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. |
40 | 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. |
41 | 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. |
42 | 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. |
43 | 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. |
44 | 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. |
45 | 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. |
46 | 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. |
47 | 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. |
48 | 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. |
49 | 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. |
50 | 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. |