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 | 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 | 00869770000241 | DFG0001 | Zio monitor | IRHYTHM TECHNOLOGIES, INC. | ||
2 | 00869770000234 | K100A101X | ZIO SR ECG Monitoring Service | ZIO SR Patch | IRHYTHM TECHNOLOGIES, INC. | |
3 | 00869770000210 | A100A100X | ZIO AT ECG Monitoring Service | ZIO AT Patch | IRHYTHM TECHNOLOGIES, INC. | |
4 | 00869770000203 | N100A102X | ZIO XT ECG Monitoring Service | ZIO XT Patch | IRHYTHM TECHNOLOGIES, INC. | |
5 | 00860002827308 | Model 950-3CH | 1 | Holter Monitor | Holter Monitor | MEMTEC CORPORATION |
6 | 00857553006139 | D300 | D300 | Cardea SOLO PC Software - ECG analysis software (D300) | Cardea SOLO | CARDIAC INSIGHT, INC. |
7 | 00857553006092 | C300/D300 | C300/D300 | StealthView Software & Smart Cable - ECG analysis software (D300) and data trans StealthView Software & Smart Cable - ECG analysis software (D300) and data transfer cable (C300). | Stealth System S300 | CARDIAC INSIGHT, INC. |
8 | 00857522005019 | s | mp3 | 3 channel Holter recorder | myPatch® | DMS-SERVICE LLC |
9 | 00856362005012 | ECG3 | iHealth | IHEALTH LAB INC. | ||
10 | 00856298006237 | Novi Software | 101633 | Software used for the interaction and programming of the Novi Device. | Novi Software | SCOTTCARE CORPORATION, THE |
11 | 00850725007088 | Lifestar AF Express | King of Hearts Express + AF Monitor | Lifestar AF Express | LIFEWATCH | |
12 | 00850725007071 | King of Hearts AF | King of Hearts Express AF Cardiac Event Recorder | King of Hearts AF | LIFEWATCH | |
13 | 00817980021396 | Model EZ | A13-0040 | EZ™ Software CD & Data Cable for ECG Monitor | Vasomedical™ EZ™ Software CD & Data Cable for ECG Monitor | VASOMEDICAL, INC. |
14 | 00817980021389 | Model EZ | A13-0001-02-01 | EZ™ ECG Monitor | Vasomedical™ EZ™ ECG Monitor | VASOMEDICAL, INC. |
15 | 00817980020733 | Model 1201 | A10-1201-06 | Electrode, Holter, Button, 1 ea., MP3E-01 | Electrode, Holter, Button, 1 ea., MP3E-01 | VASOMEDICAL, INC. |
16 | 00817980020726 | Model 1201 | A10-1201-05 | Electrodes, Holter, Button, 40 per Box, MP3E-40 | Electrodes, Holter, Button, 40 per Box, MP3E-40 | VASOMEDICAL, INC. |
17 | 00817980020719 | Model 1201 | A10-1201-04 | Electrodes, Holter, Button, 20 per Box, MP3E-20 | Electrodes, Holter, Button, 20 per Box, MP3E-20 | VASOMEDICAL, INC. |
18 | 00817980020702 | Model 1200 | A10-1200-04 | Electrode, Holter, Button, 1 ea., MP2E-01 | Electrode, Holter, Button, 1 ea., MP2E-01 | VASOMEDICAL, INC. |
19 | 00817980020696 | Model 1200 | A10-1200-03 | Electrodes, Holter, Button, 40 per Box, MP2E-40 | Electrodes, Holter, Button, 40 per Box, MP2E-40 | VASOMEDICAL, INC. |
20 | 00817980020689 | Model 1200 | A10-1200-02 | Electrodes, Holter, Button, 20 per Box, MP2E-20 | Electrodes, Holter, Button, 20 per Box, MP2E-20 | VASOMEDICAL, INC. |
21 | 00817980020672 | Model 1805 | A10-0048 | Pediatric BP Cuff (small/child) 17-25cm | Pediatric BP Cuff (small/child) 17-25cm | VASOMEDICAL, INC. |
22 | 00817980020665 | Model 1805 | A10-0047 | Adult BP Cuff (large) 32-42cm | Adult BP Cuff (large) 32-42cm | VASOMEDICAL, INC. |
23 | 00817980020658 | Model 1805 | A10-0046 | Adult BP Cuff (standard) 24-32cm | Adult BP Cuff (standard) 24-32cm | VASOMEDICAL, INC. |
24 | 00817980020641 | Model 2301 | A10-0043 | Portable case with Belt for 2301/2302 Recorders | Portable case with Belt for 2301/2302 Recorders | VASOMEDICAL, INC. |
25 | 00817980020634 | Model 1303 | A10-0050 | Portable case with Belt for 1805 Monitor | Portable case with Belt for 1805 Monitor | VASOMEDICAL, INC. |
26 | 00817980020627 | Model 1304 | A10-0042 | Portable case with Belt for 1304/1305 Recorder | Portable case with Belt for 1304/1305 Recorder | VASOMEDICAL, INC. |
27 | 00817980020610 | Model 1303 | A10-0041 | Portable Case w/Belt for 1303 Recorder | Portable Case w/Belt for 1303 Recorder | VASOMEDICAL, INC. |
28 | 00817980020603 | Model 1805 | A10-0022 | Infared Communication Adaptor | Infared Communication Adaptor | VASOMEDICAL, INC. |
29 | 00817980020597 | Model 1303 | A10-0015 | USB SD Card Reader | USB SD Card Reader | VASOMEDICAL, INC. |
30 | 00817980020580 | Model 1304 | A10-0054 | 12-Ch ECG Holter Patient Cable w/10 Leads | 12-Ch ECG Holter Patient Cable w/10 Leads | VASOMEDICAL, INC. |
31 | 00817980020573 | Model 1303 | A10-0053 | 3-Ch ECG Holter Patient Cable w/7 Leads | 3-Ch ECG Holter Patient Cable w/7 Leads | VASOMEDICAL, INC. |
32 | 00817980020566 | Model 1303 | A10-0052 | 3-Ch ECG Holter Patient Cable w/5 Leads | 3-Ch ECG Holter Patient Cable w/5 Leads | VASOMEDICAL, INC. |
33 | 00817980020559 | Model 1303 | A10-0011 | 2GB SD Memory Card | 2GB SD Memory Card | VASOMEDICAL, INC. |
34 | 00817980020542 | Model 2306 Kit | A10-2306-00 | Model 2306 12 CH/ABP COMB Recorder w/Bluetooth | Vasomedical-Biox™ Model 2306 12 CH/ABP COMB Recorder w/Bluetooth | VASOMEDICAL, INC. |
35 | 00817980020535 | Model 2305 Kit | A10-2305-00 | Model 2305 3 CH/ABP COMB Recorder w/Bluetooth | Vasomedical-Biox™ Model 2305 3 CH/ABP COMB Recorder w/Bluetooth | VASOMEDICAL, INC. |
36 | 00817980020528 | Model 2304 Kit | A10-2304-00 | Model 2304 12 CH/ABP COMB Recorder | Vasomedical-Biox™ Model 2304 12 CH/ABP COMB Recorder | VASOMEDICAL, INC. |
37 | 00817980020511 | Model 2303 Kit | A10-2303-00 | Model 2303 3 CH/ABP COMB Recorder | Vasomedical-Biox™ Model 2303 3 CH/ABP COMB Recorder | VASOMEDICAL, INC. |
38 | 00817980020504 | Model 2301 Kit | A10-2301-01 | Model 2301 3 CH/ABP COMB Recorder - 7 Lead Patient Cable | Vasomedical-Biox™ Model 2301 3 CH/ABP COMB Recorder - 7 Lead Patient Cable | VASOMEDICAL, INC. |
39 | 00817980020498 | Model 2301 Kit | A10-2301-00 | Model 2301 3 CH/ABP COMB Recorder - 5 Lead Patient Cable | Vasomedical-Biox™ Model 2301 3 CH/ABP COMB Recorder - 5 Lead Patient Cable | VASOMEDICAL, INC. |
40 | 00817980020481 | Model 1807 Kit | A10-1807-00 | Model 1807 Ambulatory Blood Pressure Recorder w/Bluetooth | Vasomedical-Biox™ Model 1807 Ambulatory Blood Pressure Recorder w/Bluetooth | VASOMEDICAL, INC. |
41 | 00817980020474 | Model 1806 Kit | A10-1806-00 | Model 1806 Ambulatory Blood Pressure Recorder | Vasomedical-Biox™ Model 1806 Ambulatory Blood Pressure Recorder | VASOMEDICAL, INC. |
42 | 00817980020467 | Model 1805 Kit | A10-1805-00 | Model 1805 Ambulatory Blood Pressure Recorder | Vasomedical-Biox™ Model 1805 Ambulatory Blood Pressure Recorder | VASOMEDICAL, INC. |
43 | 00817980020450 | Model 1308 Kit | A10-1308-00 | Model 1308 12 CH ULTRA Recorder w/Bluetooth | Vasomedical-Biox™ Model 1308 12 CH ULTRA Recorder w/Bluetooth | VASOMEDICAL, INC. |
44 | 00817980020443 | Model 1307 Kit | A10-1307-00 | Model 1307 3 CH ULTRA Recorder | Vasomedical-Biox™ Model 1307 3 CH ULTRA Recorder | VASOMEDICAL, INC. |
45 | 00817980020436 | Model 1306 Kit | A10-1306-01-04-02 | Model 1306 12 CH Recorder - 10 Lead Patient Cable | Vasomedical-Biox™ Model 1306 12 CH Recorder - 10 Lead Patient Cable | VASOMEDICAL, INC. |
46 | 00817980020429 | Model 1305 Kit | A10-1305-01-04-03 | Model 1305 3 CH Recorder - 7 Lead Patient Cable | Vasomedical-Biox™ Model 1305 3 CH Recorder - 7 Lead Patient Cable | VASOMEDICAL, INC. |
47 | 00817980020412 | Model 1305 Kit | A10-1305-01-04-00 | Model 1305 3 CH Recorder - 5 Lead Patient Cable | Vasomedical-Biox™ Model 1305 3 CH Recorder - 5 Lead Patient Cable | VASOMEDICAL, INC. |
48 | 00817980020405 | Model 1304 Kit | A10-1304-01-04-02 | Model 1304 12 CH Recorder - 10 Lead Patient Cable | Vasomedical-Biox™ Model 1304 12 CH Recorder - 10 Lead Patient Cable | VASOMEDICAL, INC. |
49 | 00817980020399 | Model 1303 Kit | A10-1303-01-04-02 | Model 1303 3 CH ULTRA Recorder w/LCD - 5 Lead Patient Cable | Vasomedical-Biox™ Model 1303 3 CH ULTRA Recorder w/LCD - 5 Lead Patient Cable | VASOMEDICAL, INC. |
50 | 00817980020382 | Model 1303 Kit | A10-1303-01-04-00 | Model 1303 3 CH ULTRA Recorder w/LCD - 7 Lead Patient Cable | Vasomedical-Biox™ Model 1303 3 CH ULTRA Recorder w/LCD - 7 Lead Patient Cable | VASOMEDICAL, INC. |