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 | B690MS10 | 1400 | MoMe® Software Platform is a web-based remote server software with proprietary a MoMe® Software Platform is a web-based remote server software with proprietary algorithms for analysis of ECG data. It analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review. The data is sent to the Software Platform from the MoMe® Kardia , a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring. | MoMe® Software Platform | INFOBIONIC, INC. | |
2 | B690MK10 | 01854 | MoMe® Kardia is a wireless, remote monitoring system designed to aid physicians MoMe® Kardia is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring. MoMe® Kardia includes the wearable device that acquires and stores ECG data and transmits that data via cellular technology to the MoMe® Software Platform, a web-based remote server software with proprietary algorithms for analysis. MoMe® Software Platform analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review. | MoMe® Kardia | INFOBIONIC, INC. | |
3 | B510PM2000TM1 | PM-2000TM | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | ||
4 | B510PM2000M1 | PM-2000M | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | ||
5 | B510PM2000APRO1 | PM-2000A PRO | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | ||
6 | B510PM2000A1 | PM-2000A | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | ||
7 | B3943950010000 | ADMS Android Software | 395-0010-00 | Athena GTX Device Management Suite - Android | Athena GTX Device Management Suite (ADMS) Software | ATHENA GTX, INC. |
8 | B3943950009000 | ADMS iOS Software | 395-0009-00 | Athena GTX Device Management Suite - iOS | Athena GTX Device Management Suite (ADMS) Software | ATHENA GTX, INC. |
9 | B3943900008000 | ADMS PC Software | 390-0008-00 | Athena GTX Device Management Suite - PC | Athena GTX Device Management Suite (ADMS) Software | ATHENA GTX, INC. |
10 | B146M10 | 100-0046-02 | C6 monitor | BRAEMAR MANUFACTURING, LLC | ||
11 | B146ELWA10 | 02-00124 | BTP-1000LW | BRAEMAR MANUFACTURING, LLC | ||
12 | B146C6S0 | 900-0634-00 | MCOT Holter | BTP-1000S | BRAEMAR MANUFACTURING, LLC | |
13 | B146C6R20 | 02-01897 | C6 Sensor 2.0 rebuilt | BRAEMAR MANUFACTURING, LLC | ||
14 | B146C6R10 | 02-01889 | C6 Sensor 2.5 rebuilt | BRAEMAR MANUFACTURING, LLC | ||
15 | B146C6M70 | 02-01804 | C6 Monitor A10e, Verizon | BRAEMAR MANUFACTURING, LLC | ||
16 | B146C6M50 | 02-01548 | BTP-1000M | BRAEMAR MANUFACTURING, LLC | ||
17 | B146C6M40 | 02-01549 | C6 Monitor | BRAEMAR MANUFACTURING, LLC | ||
18 | B146C6M20 | 100-0048-02 | C6 Monitor UGW | BRAEMAR MANUFACTURING, LLC | ||
19 | B146C6E10 | 02-01846 | C6 Sensor 3.0 | BRAEMAR MANUFACTURING, LLC | ||
20 | B146C6D10 | 02-01606 | C6 Sensor | BRAEMAR MANUFACTURING, LLC | ||
21 | B146C6D0 | 02-01561 | C6 Sensor D | BRAEMAR MANUFACTURING, LLC | ||
22 | B146C5S0 | 100-0028-02 | Ambulatory ECG Monitoring system | C5 Sensor | BRAEMAR MANUFACTURING, LLC | |
23 | B146C5M20 | 02-00116 | C5 Monitor NOBT | BRAEMAR MANUFACTURING, LLC | ||
24 | B146C5M0 | 100-0025-01 | Ambulatory ECG Monitoring system | C5 Monitor | BRAEMAR MANUFACTURING, LLC | |
25 | B146BTPM0 | 100-0045-02 | BTP-1000S Monitor | BRAEMAR MANUFACTURING, LLC | ||
26 | B146BTPL210 | 02-01560 | BTP-1000L-2 BTI | BRAEMAR MANUFACTURING, LLC | ||
27 | B146BTPA10 | 02-00143 | BTP-1000A | BRAEMAR MANUFACTURING, LLC | ||
28 | 90815187020115 | 007-400-0145 | 007-400-0145 | ECG Module USB Cable (3 meters) | USB Cable | GLOBAL INSTRUMENTATION, LLC |
29 | 90815187020108 | 6000-ECG5A | 6000-ECG5A | Module + USB + Patient Cable 5L AHA90815187020016; ECG Module90815187020009; Pa Module + USB + Patient Cable 5L AHA90815187020016; ECG Module90815187020009; Patient Cable 5L AHA90815187020023; ECG Module USB Cable (18")90815187020030; ECG Mounting Accessory, ACM, WALL | Matrix Mini ECG Module Kit | GLOBAL INSTRUMENTATION, LLC |
30 | 90815187020092 | 6000-ECG5I | 6000-ECG5I | Module + USB + Patient Cable 5L IEC90815187020016; ECG Module90815187020061; Pa Module + USB + Patient Cable 5L IEC90815187020016; ECG Module90815187020061; Patient Cable 5L IEC90815187020023; ECG Module USB Cable (18")90815187020030; ECG Mounting Accessory, ACM, WALL | Matrix Mini ECG Module Kit | GLOBAL INSTRUMENTATION, LLC |
31 | 90815187020085 | 6000-ECG3A | 6000-ECG3A | Module + USB + Patient Cable 3L AHA90815187020016; ECG Module90815187020054; Pa Module + USB + Patient Cable 3L AHA90815187020016; ECG Module90815187020054; Patient Cable 3L AHA90815187020023; ECG Module USB Cable (18")90815187020030; ECG Mounting Accessory, ACM, WALL | Matrix Mini ECG Module Kit | GLOBAL INSTRUMENTATION, LLC |
32 | 90815187020078 | 007-400-0142 | 6000-CBL3I | Patient Cable 3L IEC | Patient Cable | GLOBAL INSTRUMENTATION, LLC |
33 | 90815187020061 | 007-400-0143 | 6000-CBL5I | Patient Cable 5L IEC | Patient Cable | GLOBAL INSTRUMENTATION, LLC |
34 | 90815187020054 | 007-400-0140 | 6000-CBL3A | Patient Cable 3L AHA | Patient Cable | GLOBAL INSTRUMENTATION, LLC |
35 | 90815187020047 | 6000-ECG3I | 6000-ECG3I | Module + USB + Patient Cable 3L IEC90815187020016; ECG Module90815187020078; Pa Module + USB + Patient Cable 3L IEC90815187020016; ECG Module90815187020078; Patient Cable 3L IEC90815187020023; ECG Module USB Cable (18")90815187020030; ECG Mounting Accessory, ACM, WALL | Matrix Mini ECG Module Kit | GLOBAL INSTRUMENTATION, LLC |
36 | 90815187020030 | 007-200-0136 | 106550 | ECG Mounting Accessory, ACM, WALL | Bracket | GLOBAL INSTRUMENTATION, LLC |
37 | 90815187020023 | 007-400-0144 | 106512 | ECG Module USB Cable (18") | USB Cable | GLOBAL INSTRUMENTATION, LLC |
38 | 90815187020016 | M3U | 6000-ECG | ECG Module | Matrix Mini | GLOBAL INSTRUMENTATION, LLC |
39 | 90815187020009 | 007-400-0141 | 6000-CBL5A | Patient Cable 5L AHA | Patient Cable | GLOBAL INSTRUMENTATION, LLC |
40 | 20884838072248 | Flow Sensor Neonatal | 989803144671 | The M2786A in combination with the spirometry module M1014A is designed to allow The M2786A in combination with the spirometry module M1014A is designed to allow measurement of airway pressures, flow, minute volume, tidal volume, airway compliance, airway resistance and CO2. | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
41 | 20884838071371 | 989803105541 | 989803105541 | FilterLine/Microstream | PHILIPS MEDICAL SYSTEMS HSG | |
42 | 20884838037773 | 989803183371 | 989803183371 | NIBP Cuffs | PHILIPS MEDICAL SYSTEMS HSG | |
43 | 20884838037766 | Multi Care Cuff, Large Adult | 989803183361 | NIBP Cuffs | PHILIPS MEDICAL SYSTEMS HSG | |
44 | 20884838037759 | Multi Care Cuff, Adult | 989803183351 | NIBP Cuffs | PHILIPS MEDICAL SYSTEMS HSG | |
45 | 20884838037742 | Multi Care Cuff, Adult | 989803183341 | NIBP Cuffs | PHILIPS MEDICAL SYSTEMS HSG | |
46 | 20884838037711 | 989803183331 | 989803183331 | NIBP Cuffs | PHILIPS MEDICAL SYSTEMS HSG | |
47 | 20884838037704 | 989803183321 | 989803183321 | NIBP Cuffs | PHILIPS MEDICAL SYSTEMS HSG | |
48 | 20884838037681 | 989803183311 | 989803183311 | NIBP Cuffs | PHILIPS MEDICAL SYSTEMS HSG | |
49 | 20884838013524 | CBL ECG 5 LEAD GRABBER IEC+SPO2 SPU TELE | 989803172151 | MX40 Patient Cable consists of 5-wire ECG lead set with integrated SpO2 cable/fi MX40 Patient Cable consists of 5-wire ECG lead set with integrated SpO2 cable/finger wrap sensor for patients (. 20 kg). Grabber leads, IEC color coded (white mono color lead wires). Single Patient Use. Cable length: ECG = 85 cm (33.5 .), SpO2 = 2m (6,5 ft) 1 Sales unit = 20 patient cables. | ECG Electrodes | PHILIPS MEDICAL SYSTEMS HSG |
50 | 20884838013517 | CBL ECG 5 LEAD GRABBER IEC, SPU, TELE | 989803172131 | MX40 Patient Cable consists of 5-wire ECG lead set. Grabber leads, IEC color cod MX40 Patient Cable consists of 5-wire ECG lead set. Grabber leads, IEC color coded (white mono colorlead wires). Single Patient Use. Cable length 85 cm (33.5 .) 1 Sales unit = 20 patient cables. | ECG Electrodes | PHILIPS MEDICAL SYSTEMS HSG |