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 | 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 | 00812345029857 | HSERV-6AA-XXXXA | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
2 | 00812345029840 | HSCRIBE-6AC-YXXXC | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
3 | 00812345029826 | HSCRIBEWS-6AC-YXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
4 | 00812345027884 | S4-P-A | Electrocardiographic telemetry monitoring system transmitter | Surveyor S4 | MORTARA INSTRUMENT, INC. | |
5 | 00812345027877 | S4-Q-ASX-XXX | Electrocardiographic telemetry monitoring system transmitter | Surveyor S4 | MORTARA INSTRUMENT, INC. | |
6 | 00812345027860 | S4-Q-AXX-XXX | Electrocardiographic telemetry monitoring system transmitter | Surveyor S4 | MORTARA INSTRUMENT, INC. | |
7 | 00812345027853 | S4-Q-BSX-XXX | Electrocardiographic telemetry monitoring system transmitter | Surveyor S4 | MORTARA INSTRUMENT, INC. | |
8 | 00812345027846 | S4-Q-BXX-XXX | Electrocardiographic telemetry monitoring system transmitter | Surveyor S4 | MORTARA INSTRUMENT, INC. | |
9 | 00812345027464 | MODALITYMGR-5AE-AXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
10 | 00812345027457 | MODALITYMGR-5AD-AXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
11 | 00812345027440 | MODALITYMGR-5AC-AXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
12 | 00812345027433 | MODALITYMGR-5AC-AXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
13 | 00812345027426 | MODALITYMGR-5AC-AXXXA | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
14 | 00812345027419 | X12PLUS-BAD-XXXXX | Physiological signal transmitters and receivers | X12+ | MORTARA INSTRUMENT, INC. | |
15 | 00812345027402 | X12PLUS-BAA-XXXXX | Physiological signal transmitters and receivers | X12+ | MORTARA INSTRUMENT, INC. | |
16 | 00812345027396 | X12PLUS-BXH-XXXXX | Physiological signal transmitters and receivers | X12+ | MORTARA INSTRUMENT, INC. | |
17 | 00812345027389 | X12PLUS-BXG-XXXXX | Physiological signal transmitters and receivers | X12+ | MORTARA INSTRUMENT, INC. | |
18 | 00812345027372 | SCRIBEWS-5BB-YXXXX | Cardiology Information System Workstation | Scribe | MORTARA INSTRUMENT, INC. | |
19 | 00812345027365 | SCRIBEWS-5BA-AXXXX | Cardiology Information System Workstation | Scribe | MORTARA INSTRUMENT, INC. | |
20 | 00812345027358 | SCRIBEWS-5AB-AXXXX | Cardiology Information System Workstation | Scribe | MORTARA INSTRUMENT, INC. | |
21 | 00812345027341 | SCRIBEWS-5BC-AXXXX | Cardiology Information System Workstation | Scribe | MORTARA INSTRUMENT, INC. | |
22 | 00812345027334 | HSCRIBE-6AC-XXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
23 | 00812345027327 | SCRIBEWS-5BA-AAXXX | Cardiology Information System Workstation | Scribe | MORTARA INSTRUMENT, INC. | |
24 | 00812345027310 | SCRIBEWS-5AC-AXXXX | Cardiology Information System Workstation | Scribe | MORTARA INSTRUMENT, INC. | |
25 | 00812345027297 | SCRIBEWS-5AA-AAXXX | Cardiology Information System Workstation | Scribe | MORTARA INSTRUMENT, INC. | |
26 | 00812345027280 | HSREV-AAA-BXXAA | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
27 | 00812345027273 | HSCRIBE-5AC-XXXXB | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
28 | 00812345027266 | HSCRIBE-5AC-AXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
29 | 00812345027259 | HSCRIBE-5AB-YXXXB | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
30 | 00812345027242 | HSCRIBE-5AB-AXXXD | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
31 | 00812345027235 | HSCRIBE-5AC-YXXXD | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
32 | 00812345027228 | HSCRIBE-5AC-AXXXC | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
33 | 00812345027211 | HSCRIBE-5AC-AXXXB | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
34 | 00812345027204 | HSCRIBE-5AC-AXXXA | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
35 | 00812345027198 | HSCRIBE-5AB-AXXXB | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
36 | 00812345027181 | HSCRIBE-5AA-AXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
37 | 00812345027174 | HSCRIBE-5AA-AXXXC | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
38 | 00812345027167 | HSCRIBE-5AA-AXXXB | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
39 | 00812345027150 | HSCRIBE-5AA-AAXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
40 | 00812345027143 | HSCRIBE-5AA-AAXXC | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
41 | 00812345027136 | HSCRIBE-5AA-AAXXB | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
42 | 00812345027129 | HSCRIBE-5AA-AAXXA | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
43 | 00812345027037 | 88999-007-52 | Physiological signal transmitters and receivers | X12+ | MORTARA INSTRUMENT, INC. | |
44 | 00812345026009 | 9293-061-53 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
45 | 00812345025996 | 9293-061-52 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
46 | 00812345025989 | 9293-061-51 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
47 | 00812345025972 | 9293-061-50 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
48 | 00812345025965 | 9293-059-83 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
49 | 00812345025958 | 9293-059-82 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
50 | 00812345025941 | 9293-059-81 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. |