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 | 00884838094895 | Philips Holter Software | 860292 | Philips Holter Software w/ Zymed Alg | Holter Software | PHILIPS MEDICAL SYSTEMS HSG |
2 | 00862887000340 | PM410 | CardioPAL SAVI is a small, patient worn device, prescribed by physicians for pat CardioPAL SAVI is a small, patient worn device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia. | CardioPAL SAVI | MEDICOMP, INC. | |
3 | 00841709118067 | P/N 4-100-3140 | IQ HOLTER PLUG-IN SOFTWARE v10.0.6: New Software Release for Midmark Digital Holter. | MIDMARK IQHOLTER® PLUG-IN SOFTWARE | MIDMARK CORPORATION | |
4 | 00841709100703 | 2-100-0090 | 2-100-0090 | These kits are designed to provide the supplies you need for Holter testing. Kit These kits are designed to provide the supplies you need for Holter testing. Kit includes: a diary, two AA batteries, razor, abrading pad, two alcohol wipes and seven electrodes. | Prep Kit - Midmark IQholter, 7-lead | MIDMARK CORPORATION |
5 | 00841709100697 | 2-100-0080 | 2-100-0080 | These kits are designed to provide the supplies you need for Holter testing. Kit These kits are designed to provide the supplies you need for Holter testing. Kit contains: a diary, two AA batteries, razor, abrading pad, two alcohol wipes and five electrodes. | Prep Kit - Midmark IQholter, 5-lead | MIDMARK CORPORATION |
6 | 00841709100659 | 1-370-0005 | 1-370-0005 | Small and lightweight digital Holter recorder. Standard 24-hour recording with Small and lightweight digital Holter recorder. Standard 24-hour recording with 48 and 72-hour recording capabilities available. | Midmark IQholter® Digital Holter Recorder | MIDMARK CORPORATION |
7 | 00841709100628 | 4-000-0119 | 4-000-0119 | Small and lightweight digital Holter recorder. Standard 24-hour recording with Small and lightweight digital Holter recorder. Standard 24-hour recording with 48 and 72-hour recording capabilities available. Midmark IQHolter Recorder, Lead wire set, Secure Digital Card, Four Holter Prep Kits, and Reusable IQholter Recorder Pouch and Belt. | Midmark IQholter® Digital Holter Recorder Kit | MIDMARK CORPORATION |
8 | 00841709100611 | 4-000-0116 | 4-000-0116 | The Midmark IQholter® EP system combines a compact digital recorder with three p The Midmark IQholter® EP system combines a compact digital recorder with three powerful software applications. Includes all the features of IQholter® EX plus Pacemaker detection of single and dual-chamber paced beats for non-captures and sensing failures.situations in fast-paced offices. Kit includes: Midmark IQholter EP with Pacemaker Detection, Midmark IQholter Recorder (includes Lead Wire Set, Secure Digital Card), Reusable IQholter Recorder Pouch and Belt, Secure Digital Card Reader, Software Security Key, USB Version, and Holter Prep Kits. | Midmark IQholter® EP Digital Holter | MIDMARK CORPORATION |
9 | 00841709100604 | 4-000-0113 | 4-000-0113 | The Midmark IQholter EX system combines a compact digital recorder with three po The Midmark IQholter EX system combines a compact digital recorder with three powerful software applications. Includes the standard features of IQholter with expanded functionality for A-Fib, QT/QTc and HRV analysis, template editing, Smart Page Scan and more. Kit includes: Midmark IQholter Recorder (includes lead wire set, secure digital card), Reusable IQholter Recorder pouch and Belt, Secure Digital Card Reader, Software Security Key, USB Version, and Holter Prep Kits. | Midmark IQholter EX Digital Holter | MIDMARK CORPORATION |
10 | 00841709100598 | 4-000-0110 | 4-000-0110 | The Midmark IQholter system combines a compact digital recorder with three power The Midmark IQholter system combines a compact digital recorder with three powerful software applications. Easy-to-use Holter software with fully automated analysis and reporting, designed for routine monitoring situations in fast-paced offices. Kit includes: Midmark IQholter Recorder (includes lead wire set, secure digital card), Reusable IQholter Recorder Pouch and Belt, Secure Digital Card Reader, Software Security Key USB Version, and Holter Prep Kits. | Midmark IQholter Digital Holter | MIDMARK CORPORATION |
11 | 00817655022642 | 11100-005-50 | Holter Analysis System Software | Vision | MORTARA INSTRUMENT, INC. | |
12 | 00817655022635 | 11110-005-50 | Holter Analysis System Software | HScribe | MORTARA INSTRUMENT, INC. | |
13 | 00817655022529 | HSCRIBWS-6BC-YXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
14 | 00817655022512 | HSCRIBWS-6BC-XXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
15 | 00817655022505 | HSCRIBWS-6BC-DXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
16 | 00817655022499 | HSCRIBWS-6BC-BXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
17 | 00817655022482 | HSCRIBWS-6BA-CXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
18 | 00817655022475 | MDLTYMGR-5BC-XXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
19 | 00817655022468 | MDLTYMGR-5BC-DXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
20 | 00817655022451 | MDLTYMGR-5AE-AXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
21 | 00817655022444 | MDLTYMGR-5AD-AXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
22 | 00817655022437 | MDLTYMGR-5AC-XXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
23 | 00817655022420 | MDLTYMGR-5AC-XXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
24 | 00817655022413 | MDLTYMGR-5AC-XXXXA | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
25 | 00817655022406 | MDLTYMGR-5AC-DXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
26 | 00817655022390 | MDLTYMGR-5AC-DXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
27 | 00817655022383 | MDLTYMGR-5AC-DXXXA | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
28 | 00817655022376 | MDLTYMGR-5AC-CXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
29 | 00817655022369 | MDLTYMGR-5AC-CXXXA | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
30 | 00817655022352 | MDLTYMGR-5AC-BXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
31 | 00817655022345 | MDLTYMGR-5AC-BXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
32 | 00817655022338 | MDLTYMGR-5AC-BXXXA | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
33 | 00817655022321 | MDLTYMGR-5AC-AXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
34 | 00817655022314 | MDLTYMGR-5AC-AXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
35 | 00817655022307 | MDLTYMGR-5AC-AXXXA | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
36 | 00817655022291 | MDLTYMGR-5AA-AXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
37 | 00817655022284 | HSCRIBWS-6AC-YXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
38 | 00817655022277 | HSCRIBWS-6AC-XXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
39 | 00817655022260 | HSCRIBWS-6AC-DXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
40 | 00817655022253 | MDLTYMGR-5AA-AXXXA | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
41 | 00817655022239 | HSCRIBE-6AC-AXXXA | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
42 | 00817655022161 | HSCRIBE-6AC-YXXXB | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
43 | 00817655021904 | HSERV-6BA-XXXXA | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
44 | 00817655021829 | HSCRIBE-6AC-YXXXA | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
45 | 00817655021744 | HSCRIBE-6AC-AXXXB | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
46 | 00817655021461 | HSCRIBE-EYA-BXXXX | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
47 | 00817655021102 | HSCRIBE-6AA-AAXXA | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
48 | 00817655021096 | HSCRIBE-6AB-AXXXC | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
49 | 00817655021089 | HSCRIBE-6AB-AXXXB | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. | |
50 | 00817655021072 | HSCRIBE-6AB-AXXXA | Holter Analysis System | HScribe | MORTARA INSTRUMENT, INC. |