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 | 00812345029895 | 33193-106-50 | Cardiac and pulmonary rehabilitation data acquisition and editing system | Q-Tel RMS | MORTARA INSTRUMENT, INC. | |
2 | 00812345029888 | 33193-104-50 | Cardiac and pulmonary rehabilitation data acquisition and editing system | Q-Tel RMS | MORTARA INSTRUMENT, INC. | |
3 | 00812345029642 | QTELS-P-XX | Cardiac and pulmonary rehabilitation data acquisition and editing system | Q-Tel RMS | MORTARA INSTRUMENT, INC. | |
4 | 00812345029635 | QTELS-P-AC | Cardiac and pulmonary rehabilitation data acquisition and editing system | Q-Tel RMS | MORTARA INSTRUMENT, INC. | |
5 | 00812345029628 | QTELS-P-AB | Cardiac and pulmonary rehabilitation data acquisition and editing system | Q-Tel RMS | MORTARA INSTRUMENT, INC. | |
6 | 00812345029611 | QTELS-P-AA | Cardiac and pulmonary rehabilitation data acquisition and editing system | Q-Tel RMS | MORTARA INSTRUMENT, INC. | |
7 | 00812345029604 | QTELM-P-XXXX | Cardiac and pulmonary rehabilitation data acquisition and editing system | Q-Tel RMS | MORTARA INSTRUMENT, INC. | |
8 | 00812345029598 | QTELM-P-ACXX | Cardiac and pulmonary rehabilitation data acquisition and editing system | Q-Tel RMS | MORTARA INSTRUMENT, INC. | |
9 | 00812345029581 | QTELM-P-ACXA | Cardiac and pulmonary rehabilitation data acquisition and editing system | Q-Tel RMS | MORTARA INSTRUMENT, INC. | |
10 | 00812345029574 | QTELM-P-ACAX | Cardiac and pulmonary rehabilitation data acquisition and editing system | Q-Tel RMS | MORTARA INSTRUMENT, INC. | |
11 | 00812345029567 | QTELM-P-ACAA | Cardiac and pulmonary rehabilitation data acquisition and editing system | Q-Tel RMS | MORTARA INSTRUMENT, INC. | |
12 | 00812345029550 | QTELM-P-ABXX | Cardiac and pulmonary rehabilitation data acquisition and editing system | Q-Tel RMS | MORTARA INSTRUMENT, INC. | |
13 | 00812345029543 | QTELM-P-ABXA | Cardiac and pulmonary rehabilitation data acquisition and editing system | Q-Tel RMS | MORTARA INSTRUMENT, INC. | |
14 | 00812345029536 | QTELM-P-ABAX | Cardiac and pulmonary rehabilitation data acquisition and editing system | Q-Tel RMS | MORTARA INSTRUMENT, INC. | |
15 | 00812345029529 | QTELM-P-ABAA | Cardiac and pulmonary rehabilitation data acquisition and editing system | Q-Tel RMS | MORTARA INSTRUMENT, INC. | |
16 | 00812345029512 | QTELM-P-AAXX | Cardiac and pulmonary rehabilitation data acquisition and editing system | Q-Tel RMS | MORTARA INSTRUMENT, INC. | |
17 | 00812345029505 | QTELM-P-AAXA | Cardiac and pulmonary rehabilitation data acquisition and editing system | Q-Tel RMS | MORTARA INSTRUMENT, INC. | |
18 | 00812345029499 | QTELM-P-AAAX | Cardiac and pulmonary rehabilitation data acquisition and editing system | Q-Tel RMS | MORTARA INSTRUMENT, INC. | |
19 | 00812345029482 | QTELM-P-AAAA | Cardiac and pulmonary rehabilitation data acquisition and editing system | Q-Tel RMS | MORTARA INSTRUMENT, INC. | |
20 | 00763000562632 | LNQ11 | MON LNQ11 REVEAL LINQ USA | Reveal LINQ™ | MEDTRONIC, INC. | |
21 | 00763000562625 | LNQ11 | MON LNQ11 REVEAL LINQ USA | Reveal LINQ™ | MEDTRONIC, INC. | |
22 | 00763000554002 | LNQ22 | ICM LNQ22 LINQ II USA | LINQ II™ | MEDTRONIC, INC. | |
23 | 00763000180904 | PA97000 | ACTV PA97000 USA | NA | MEDTRONIC, INC. | |
24 | 00763000162191 | LNQ22TK | TOOL KIT LNQ22TK LINQ II USA | LINQ II™ | MEDTRONIC, INC. | |
25 | 00763000065744 | SEEQ14 | EXT CARDIAC SEEQ14 4WK KIT US PHAR TUV | SEEQ™ | MEDTRONIC, INC. | |
26 | 00763000065737 | SEEQ13 | EXT CARDIAC SEEQ13 3WK KIT US PHAR TUV | SEEQ™ | MEDTRONIC, INC. | |
27 | 00763000065720 | AVIVO1E | EXT CARDIAC AVIVO1E SEN US PHAR TUV | AVIVO™ | MEDTRONIC, INC. | |
28 | 00763000065713 | AVIVO1T | EXT CARDIAC AVIVO1T TRAN US PHAR TUV | AVIVO™ | MEDTRONIC, INC. | |
29 | 00763000065706 | AVIVO11 | EXT CARDIAC AVIVO11 1WK KIT US PHAR TUV | AVIVO™ | MEDTRONIC, INC. | |
30 | 00763000065669 | SEEQ1E | EXT CARDIAC SEEQ1E SEN US PHAR TUV | SEEQ™ | MEDTRONIC, INC. | |
31 | 00763000065652 | SEEQ1T | EXT CARDIAC SEEQ1T TRAN US PHAR TUV | SEEQ™ | MEDTRONIC, INC. | |
32 | 00763000065645 | SEEQ12 | EXT CARDIAC SEEQ12 2WK KIT US PHAR TUV | SEEQ™ | MEDTRONIC, INC. | |
33 | 00763000065638 | SEEQ11 | EXT CARDIAC SEEQ11 1WK KIT US PHAR TUV | SEEQ™ | MEDTRONIC, INC. | |
34 | 00763000060428 | 24967 | HEAD 24967 FRU US PATIENT CONN | NA | MEDTRONIC, INC. | |
35 | 00763000060374 | LNQ22 | ICM LNQ22 LINQ II USA | LINQ II™ | MEDTRONIC, INC. | |
36 | 00763000057213 | SEEQ14 | EXT CARDIAC SEEQ14 4WK KIT US TUV | SEEQ™ | MEDTRONIC, INC. | |
37 | 00763000057206 | SEEQ13 | EXT CARDIAC SEEQ13 3WK KIT US TUV | SEEQ™ | MEDTRONIC, INC. | |
38 | 00763000057190 | SEEQ12 | EXT CARDIAC SEEQ12 2WK KIT US TUV | SEEQ™ | MEDTRONIC, INC. | |
39 | 00763000057176 | SEEQ1E | EXT CARDIAC SEEQ1E SENSOR US TUV | SEEQ™ | MEDTRONIC, INC. | |
40 | 00763000057152 | SEEQ1T | EXT CARDIAC SEEQ1T TRANS US TUV | SEEQ™ | MEDTRONIC, INC. | |
41 | 00763000057138 | SEEQ11 | EXT CARDIAC SEEQ11 1WK KIT US TUV | SEEQ™ | MEDTRONIC, INC. | |
42 | 00643169855519 | 24967 | HEAD 24967 FRU US PATIENT CONN | NA | MEDTRONIC, INC. | |
43 | 00643169845893 | LNQ11 | MON LNQ11 REVEAL LINQ USA FW2.0 | Reveal LINQ™ | MEDTRONIC, INC. | |
44 | 00643169845749 | LNQ11 | MON LNQ11 REVEAL LINQ USA FW2.0 | Reveal LINQ™ | MEDTRONIC, INC. | |
45 | 00643169782730 | 24965 | MONITOR 24965 USA MKT EIFU | NA | MEDTRONIC, INC. | |
46 | 00643169732216 | LNQ11 | MON LNQ11 REVEAL LINQ USA RRT | Reveal LINQ TM | MEDTRONIC, INC. | |
47 | 00643169651180 | AVIVO11 | EXT CARDIAC MON AVIVO11 1WK KIT US | AVIVO™ | MEDTRONIC, INC. | |
48 | 00643169636651 | MSW002 | SW MSW002 LINQ PROGRAMMER iOS APP | Reveal LINQ™ Mobile Manager | MEDTRONIC, INC. | |
49 | 00643169617254 | 24965 | RF HEAD 24965 PT CONNECTOR US | NA | MEDTRONIC, INC. | |
50 | 00643169571129 | PA96000 | ACTV PA96000 PA US | N/A | MEDTRONIC, INC. |