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 | 00817644020154 | 6055325A1 | Genesis Touch TAB E ATT | MOBILEHELP, LLC | ||
2 | 00817644020147 | 6055423B1 | Genesis Touch Tab A | MOBILEHELP, LLC | ||
3 | 00817644020130 | 6055323B1 | Genesis Touch Tab E 32 GB | MOBILEHELP, LLC | ||
4 | 00817644020123 | 6053001RE1 | Genesis DM w OM NIBP | MOBILEHELP, LLC | ||
5 | 00817644020116 | 6053000RE1 | Genesis DM w ST NIBP 2 | MOBILEHELP, LLC | ||
6 | 00817644020109 | 6052001RE1 | Genesis DM2 w OM NIBP | MOBILEHELP, LLC | ||
7 | 00817644020093 | 6052000RE1 | Genesis DM2 w ST NIBP | MOBILEHELP, LLC | ||
8 | 00817644020086 | 6050000RE1 | Genesis DM w ST NIBP 1 | MOBILEHELP, LLC | ||
9 | 00817644020079 | 5 | LifeStream Application | MOBILEHELP, LLC | ||
10 | 00817644020055 | 6055023B1 | Genesis Touch TAB 2 | MOBILEHELP, LLC | ||
11 | 00817644020048 | 6053000A1 | Genesis DM Pro BP | MOBILEHELP, LLC | ||
12 | 00817644020031 | 6055123B1 | Genesis Touch TAB 4 | MOBILEHELP, LLC | ||
13 | 00817644020024 | 3 | Genesis Touch Application | MOBILEHELP, LLC | ||
14 | 00817644020017 | 6055223B1 | Genesis Touch TAB E | MOBILEHELP, LLC | ||
15 | 00812345027884 | S4-P-A | Electrocardiographic telemetry monitoring system transmitter | Surveyor S4 | MORTARA INSTRUMENT, INC. | |
16 | 00812345027877 | S4-Q-ASX-XXX | Electrocardiographic telemetry monitoring system transmitter | Surveyor S4 | MORTARA INSTRUMENT, INC. | |
17 | 00812345027860 | S4-Q-AXX-XXX | Electrocardiographic telemetry monitoring system transmitter | Surveyor S4 | MORTARA INSTRUMENT, INC. | |
18 | 00812345027853 | S4-Q-BSX-XXX | Electrocardiographic telemetry monitoring system transmitter | Surveyor S4 | MORTARA INSTRUMENT, INC. | |
19 | 00812345027846 | S4-Q-BXX-XXX | Electrocardiographic telemetry monitoring system transmitter | Surveyor S4 | MORTARA INSTRUMENT, INC. | |
20 | 00812345027419 | X12PLUS-BAD-XXXXX | Physiological signal transmitters and receivers | X12+ | MORTARA INSTRUMENT, INC. | |
21 | 00812345027402 | X12PLUS-BAA-XXXXX | Physiological signal transmitters and receivers | X12+ | MORTARA INSTRUMENT, INC. | |
22 | 00812345027396 | X12PLUS-BXH-XXXXX | Physiological signal transmitters and receivers | X12+ | MORTARA INSTRUMENT, INC. | |
23 | 00812345027389 | X12PLUS-BXG-XXXXX | Physiological signal transmitters and receivers | X12+ | MORTARA INSTRUMENT, INC. | |
24 | 00812345027037 | 88999-007-52 | Physiological signal transmitters and receivers | X12+ | MORTARA INSTRUMENT, INC. | |
25 | 00812345026009 | 9293-061-53 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
26 | 00812345025996 | 9293-061-52 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
27 | 00812345025989 | 9293-061-51 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
28 | 00812345025972 | 9293-061-50 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
29 | 00812345025965 | 9293-059-83 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
30 | 00812345025958 | 9293-059-82 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
31 | 00812345025941 | 9293-059-81 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
32 | 00812345025934 | 9293-059-80 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
33 | 00812345025927 | 9293-059-71 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
34 | 00812345025910 | 9293-059-70 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
35 | 00812345025903 | 9293-059-63 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
36 | 00812345025897 | 9293-059-62 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
37 | 00812345025880 | 9293-059-61 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
38 | 00812345025873 | 9293-059-60 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
39 | 00812345025866 | 9293-059-53 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
40 | 00812345025859 | 9293-059-52 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
41 | 00812345025842 | 9293-059-51 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
42 | 00812345025835 | 9293-059-50 | Patient cable cleared with S4 transmitter | Surveyor Patient Cable | MORTARA INSTRUMENT, INC. | |
43 | 00812345024968 | 9293-034-51 | Patient cable cleared with X12+ | X12+ Patient Cable | MORTARA INSTRUMENT, INC. | |
44 | 00812345024661 | S4-P-B | Electrocardiographic telemetry monitoring system transmitter | Surveyor S4 | MORTARA INSTRUMENT, INC. | |
45 | 00812345023466 | 9293-025-51 | Patient cable cleared with X12+ | X12+ Patient Cable | MORTARA INSTRUMENT, INC. | |
46 | 00812345023015 | 9293-034-50 | Patient cable cleared with X12+ | X12+ Patient Cable | MORTARA INSTRUMENT, INC. | |
47 | 00812345023008 | 9293-025-50 | Patient cable cleared with X12+ | X12+ Patient Cable | MORTARA INSTRUMENT, INC. | |
48 | 00804084000112 | BPM 0001 | BP Manager | IDEAL LIFE BP-Managerâ„¢ | IDEAL LIFE INC | |
49 | 00763000001964 | 100011-032 | HUB TC210 LINKVIEW | Linkview | MEDTRONIC CARE MANAGEMENT SERVICES, LLC | |
50 | 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. |