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 | 00817655022642 | 11100-005-50 | Holter Analysis System Software | Vision | MORTARA INSTRUMENT, INC. | |
2 | 00817655022635 | 11110-005-50 | Holter Analysis System Software | HScribe | MORTARA INSTRUMENT, INC. | |
3 | 00817655022529 | HSCRIBWS-6BC-YXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
4 | 00817655022512 | HSCRIBWS-6BC-XXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
5 | 00817655022505 | HSCRIBWS-6BC-DXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
6 | 00817655022499 | HSCRIBWS-6BC-BXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
7 | 00817655022482 | HSCRIBWS-6BA-CXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
8 | 00817655022475 | MDLTYMGR-5BC-XXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
9 | 00817655022468 | MDLTYMGR-5BC-DXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
10 | 00817655022451 | MDLTYMGR-5AE-AXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
11 | 00817655022444 | MDLTYMGR-5AD-AXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
12 | 00817655022437 | MDLTYMGR-5AC-XXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
13 | 00817655022420 | MDLTYMGR-5AC-XXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
14 | 00817655022413 | MDLTYMGR-5AC-XXXXA | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
15 | 00817655022406 | MDLTYMGR-5AC-DXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
16 | 00817655022390 | MDLTYMGR-5AC-DXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
17 | 00817655022383 | MDLTYMGR-5AC-DXXXA | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
18 | 00817655022376 | MDLTYMGR-5AC-CXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
19 | 00817655022369 | MDLTYMGR-5AC-CXXXA | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
20 | 00817655022352 | MDLTYMGR-5AC-BXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
21 | 00817655022345 | MDLTYMGR-5AC-BXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
22 | 00817655022338 | MDLTYMGR-5AC-BXXXA | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
23 | 00817655022321 | MDLTYMGR-5AC-AXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
24 | 00817655022314 | MDLTYMGR-5AC-AXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
25 | 00817655022307 | MDLTYMGR-5AC-AXXXA | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
26 | 00817655022291 | MDLTYMGR-5AA-AXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
27 | 00817655022284 | HSCRIBWS-6AC-YXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
28 | 00817655022277 | HSCRIBWS-6AC-XXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
29 | 00817655022260 | HSCRIBWS-6AC-DXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
30 | 00817655022253 | MDLTYMGR-5AA-AXXXA | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
31 | 00817655022239 | HSCRIBE-6AC-AXXXA | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
32 | 00817655022161 | HSCRIBE-6AC-YXXXB | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
33 | 00817655021904 | HSERV-6BA-XXXXA | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
34 | 00817655021829 | HSCRIBE-6AC-YXXXA | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
35 | 00817655021744 | HSCRIBE-6AC-AXXXB | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
36 | 00817655021461 | HSCRIBE-EYA-BXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
37 | 00817655021102 | HSCRIBE-6AA-AAXXA | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
38 | 00817655021096 | HSCRIBE-6AB-AXXXC | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
39 | 00817655021089 | HSCRIBE-6AB-AXXXB | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
40 | 00817655021072 | HSCRIBE-6AB-AXXXA | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
41 | 00817655020860 | 901143 | HSCRIBE-6AA-CXXXX | HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia a HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU and color LCD 24 in. monitor with 1920 x 1080 resolution; UK power cord; No printer; No connectivity | Welch Allyn, Inc. | WELCH ALLYN, INC. |
42 | 00817655020716 | HSCRIBE-6AC-AXXXD | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
43 | 00817655020655 | V51-1GI | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
44 | 00817655020587 | SCRIBEWS-5AC-XXXXX | Cardiology Information System Workstation | Scribe | MORTARA INSTRUMENT, INC. | |
45 | 00817655020570 | HSCRIBE-6AA-AXXXA | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
46 | 00817655020563 | HSERV-6BA-XXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
47 | 00817655020457 | SCRIBEWS-5BC-XXXXX | Cardiology Information System Workstation | Scribe | MORTARA INSTRUMENT, INC. | |
48 | 00817655020426 | HSCRIBE-6AA-AAXXE | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
49 | 00817655020396 | HSCRIBEWS-6BC-XXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
50 | 00817655020389 | HSCRIBEWS-6AC-XXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. |