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 | B146ERW3G030 | 900-0614-03 | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | ER9W 3GSM Life Support | ||
12 | B146ER9WLS0 | 900-0581-44 | Wireless Arrhythmia Event Recorder | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | ER920W Life Support | |
13 | B146ER9WFCM0 | 900-0581-57 | Wireless Arrhythmia Event Recorder | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | ER920W First-Call Medical | |
14 | B146ER9WCL0 | 900-0581-58 | Wireless Arrhythmia Event Recorder | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | ER920W CardioLabs | |
15 | B146EPE30 | 390-0240-02 | IKD | Cable, Electrode | ePatch electrode-patch | |||
16 | B146EP2R10 | 02-01997 | DSH | Recorder, Magnetic Tape, Medical | 2 | ePatch 2.0 rebuilt | ||
17 | B146EP2020 | 02-01650 | DSH | Recorder, Magnetic Tape, Medical | 2 | ePatch 2.0 BTI | ||
18 | B146EP080 | 900-0632-05 | DSH | Recorder, Magnetic Tape, Medical | 2 | Epatch Sensor | ||
19 | B146EP070 | 900-0632-04 | DSH | Recorder, Magnetic Tape, Medical | 2 | Epatch Sensor | ||
20 | B146EP060 | 900-0632-03 | DSH | Recorder, Magnetic Tape, Medical | 2 | Epatch Sensor | ||
21 | B146EP04 | 900-0632-02 | DSH | Recorder, Magnetic Tape, Medical | 2 | Epatch Sensor | ||
22 | B146ECAT2010 | 900-0623-01 | DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 2 | ECAT2 Generic | ||
23 | B146DL9ZW0 | 900-0570-25 | MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 2 | DL900 | ||
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 | 00812345027884 | S4-P-A | Electrocardiographic telemetry monitoring system transmitter | Surveyor S4 | MORTARA INSTRUMENT, INC. | |
2 | 00812345027877 | S4-Q-ASX-XXX | Electrocardiographic telemetry monitoring system transmitter | Surveyor S4 | MORTARA INSTRUMENT, INC. | |
3 | 00812345027860 | S4-Q-AXX-XXX | Electrocardiographic telemetry monitoring system transmitter | Surveyor S4 | MORTARA INSTRUMENT, INC. | |
4 | 00812345027853 | S4-Q-BSX-XXX | Electrocardiographic telemetry monitoring system transmitter | Surveyor S4 | MORTARA INSTRUMENT, INC. | |
5 | 00812345027846 | S4-Q-BXX-XXX | Electrocardiographic telemetry monitoring system transmitter | Surveyor S4 | MORTARA INSTRUMENT, INC. | |
6 | 00812345027419 | X12PLUS-BAD-XXXXX | Physiological signal transmitters and receivers | X12+ | MORTARA INSTRUMENT, INC. | |
7 | 00812345027402 | X12PLUS-BAA-XXXXX | Physiological signal transmitters and receivers | X12+ | MORTARA INSTRUMENT, INC. | |
8 | 00812345027396 | X12PLUS-BXH-XXXXX | Physiological signal transmitters and receivers | X12+ | MORTARA INSTRUMENT, INC. | |
9 | 00812345027389 | X12PLUS-BXG-XXXXX | Physiological signal transmitters and receivers | X12+ | MORTARA INSTRUMENT, INC. | |
10 | 00812345027037 | 88999-007-52 | Physiological signal transmitters and receivers | X12+ | MORTARA INSTRUMENT, INC. | |
11 | 00812345026009 | 9293-061-53 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
12 | 00812345025996 | 9293-061-52 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
13 | 00812345025989 | 9293-061-51 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
14 | 00812345025972 | 9293-061-50 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
15 | 00812345025965 | 9293-059-83 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
16 | 00812345025958 | 9293-059-82 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
17 | 00812345025941 | 9293-059-81 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
18 | 00812345025934 | 9293-059-80 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
19 | 00812345025927 | 9293-059-71 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
20 | 00812345025910 | 9293-059-70 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
21 | 00812345025903 | 9293-059-63 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
22 | 00812345025897 | 9293-059-62 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
23 | 00812345025880 | 9293-059-61 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
24 | 00812345025873 | 9293-059-60 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
25 | 00812345025866 | 9293-059-53 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
26 | 00812345025859 | 9293-059-52 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
27 | 00812345025842 | 9293-059-51 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
28 | 00812345025835 | 9293-059-50 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
29 | 00812345024968 | 9293-034-51 | Patient cable cleared with X12+ | X12+ Patient Cable | MORTARA INSTRUMENT, INC. | |
30 | 00812345024661 | S4-P-B | Electrocardiographic telemetry monitoring system transmitter | Surveyor S4 | MORTARA INSTRUMENT, INC. | |
31 | 00812345023466 | 9293-025-51 | Patient cable cleared with X12+ | X12+ Patient Cable | MORTARA INSTRUMENT, INC. | |
32 | 00812345023015 | 9293-034-50 | Patient cable cleared with X12+ | X12+ Patient Cable | MORTARA INSTRUMENT, INC. | |
33 | 00812345023008 | 9293-025-50 | Patient cable cleared with X12+ | X12+ Patient Cable | MORTARA INSTRUMENT, INC. | |
34 | 00804084000112 | BPM 0001 | BP Manager | IDEAL LIFE BP-Manager™ | IDEAL LIFE INC | |
35 | 00763000001964 | 100011-032 | HUB TC210 LINKVIEW | Linkview | MEDTRONIC CARE MANAGEMENT SERVICES, LLC | |
36 | 00732094327090 | 901138 | SUR12-TDH-XXAAX | Surveyor S12 GEN2 Patient Monitoring System - Surveyor Sp02, ECG, Dual Temp, NIB Surveyor S12 GEN2 Patient Monitoring System - Surveyor Sp02, ECG, Dual Temp, NIBP, No IBP, resistive color touchscreen 11.6" display with 1366 x 768 resolution, AC or lithium ion rechargeable battery operation; International power cord; AM12 Wired Acquisition Module with AHA 12-lead lead set with snap ends and 1 IEC 5 wire ECG patient cable with clip ends; No invasive blood pressure cable; No cardiac output cable; Internal thermal printer (includes starter pack of thermal paper roll, 1.97 in. x | Welch Allyn, Inc. | WELCH ALLYN, INC. |
37 | 00732094283464 | 901150 | X12PLUS-BDB-XXXXX | X12+ 12-lead Telemetry Transmitter - 608 MHz, graphic display, alkaline battery, X12+ 12-lead Telemetry Transmitter - 608 MHz, graphic display, alkaline battery, carry case, and hookup kit; German language and CD manual; IEC 10-wire, 12-lead LeadForm 38 in. (97cm) patient cable with snap ends | Welch Allyn, Inc. | WELCH ALLYN, INC. |
38 | 00732094279832 | 901006 | 41000-033-50 | PRINTER KIT SURVEYOR S19 | Welch Allyn, Inc. | WELCH ALLYN, INC. |
39 | 00732094272581 | 901011 | 10-00189-01 | KIT TXMR X12 4-WIRE LONG AHA | Welch Allyn, Inc. | WELCH ALLYN, INC. |
40 | 00707387766597 | TS1200CL | TS1200CL | TS1200CL TELESTETH SOFTWARE HOSTED LICENSE | Littmann® Telesteth™ | 3M COMPANY |
41 | 00643169838451 | 100011-022 | HUB TC200 LINKVIEW | Linkview® | MEDTRONIC CARE MANAGEMENT SERVICES, LLC | |
42 | B595L2050G0 | L2050G Adapter | L2050G | The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use b The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure, and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.The Vios Chest Sensor and Adapter are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients. | Vios Montioring System Adapter | MURATA VIOS PRIVATE LIMITED |
43 | B595CS20500 | CS2050 Chest Sensor | CS2050 | The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use b The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure, and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.The Vios Chest Sensor and Adapter are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients. | Vios Monitoring System Chest Sensor | MURATA VIOS PRIVATE LIMITED |
44 | B595BSM20500 | BSM2050 Software | BSM2050 | The Vios Monitoring System (VMS) Bedside Monitor is intended for use by medicall The Vios Monitoring System (VMS) Bedside Monitor is intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure, and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.The VMS Bedside Monitor is intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients. | Vios Monitoring System Bedside Monitor | MURATA VIOS PRIVATE LIMITED |
45 | B493SW0028 | SW-0028 | Web application | BioStamp nPoint™ | MC10, INC. | |
46 | B493SW0027 | SW-0027 | Investigator application for Android | BioStamp nPoint™ | MC10, INC. | |
47 | B493SW0026 | SW-0027 | Sync application for Android | BioStamp nPoint™ | MC10, INC. | |
48 | B493SW0025 | SW-0025 | Link application for Android | BioStamp nPoint™ | MC10, INC. | |
49 | B493MC0015 | MC-0015 | MC-0015 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05 | BioStamp nPoint™ | MC10, INC. | |
50 | B493MC0014 | MC-0014 | MC-0014 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BRCT01, B493B MC-0014 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BRCT01, B493BSPS01, B493BRCA05 | BioStamp nPoint™ | MC10, INC. |