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 | 00659443002722 | H20KT | H20KT | High Flow Rate Kit (2 x F275, 5 x F600, 5 x F900, 4 x F1200, 4 x F2400) | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
2 | 00659443002715 | L20KT | L20KT | Low Flow Rate Kit (3 x F30, 2 x F45, 8 x F60, 4 x F120, 3 x F180) | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
3 | 00659443000704 | VHF | VHF | Flow Control Infusion Tubing VHF | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
4 | 00659443000698 | FEXT | FEXT | 24" Tubing Extender | HIgH-Flo™, RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
5 | 00659443000681 | LRVY | LRVY | Low Residual Volume Y-Connector | HIgH-Flo™ | REPRO MED SYSTEMS, INC. |
6 | 00659443000223 | F2400 | F2400 | Flow Control Infusion Tubing | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
7 | 00659443000216 | F1200 | F1200 | Flow Control Infusion Tubing | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
8 | 00659443000209 | F900 | F900 | Flow Control Infusion Tubing | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
9 | 00659443000193 | F600 | F600 | Flow Control Infusion Tubing | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
10 | 00659443000186 | F500 | F500 | Flow Control Infusion Tubing | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
11 | 00659443000179 | F420 | F420 | Flow Control Infusion Tubing | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
12 | 00659443000162 | F275 | F275 | Flow Control Infusion Tubing | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
13 | 00659443000155 | F180 | F180 | Flow Control Infusion Tubing | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
14 | 00659443000148 | F120 | F120 | Flow Control Infusion Tubing | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
15 | 00659443000131 | F60 | F60 | Flow Control Infusion Tubing | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
16 | 00659443000124 | F45 | F45 | Flow Control Infusion Tubing | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
17 | 00659443000117 | F30 | F30 | Flow Control Infusion Tubing | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
18 | 00659443000100 | F15 | F15 | Flow Control Infusion Tubing | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
19 | 00659443000094 | F10 | F10 | Flow Control Infusion Tubing | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
20 | 00659443000087 | F8 | F8 | Flow Control Infusion Tubing | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
21 | 00659443000070 | F5 | F5 | Flow Control Infusion Tubing | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
22 | 00659443000063 | F3.8 | F3.8 | Flow Control Infusion Tubing | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
23 | 00659443000056 | F3 | F3 | Flow Control Infusion Tubing | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
24 | 00659443000049 | F2 | F2 | Flow Control Infusion Tubing | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
25 | 00659443000032 | F1 | F1 | Flow Control Infusion Tubing | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
26 | 00659443000025 | F0.5 | F0.5 | Flow Control Infusion Tubing | RMS Precision Flow Rate TubingTM | REPRO MED SYSTEMS, INC. |
27 | 00659443000018 | F10020 | F10020 | Mechanical Syringe Infusion Pump | FreedomEdgeTM | REPRO MED SYSTEMS, INC. |
28 | 00659443000001 | F10050 | F10050 | Mechanical Syringe Infusion Pump | FREEDOM60® | REPRO MED SYSTEMS, INC. |
29 | 00646311550928 | PI01Y23 | PORT ACCESS INFUSION SET | SB-KAWASUMI LABORATORIES, INC. | ||
30 | 00646311550911 | PI01Y93 | PORT ACCESS INFUSION SET | SB-KAWASUMI LABORATORIES, INC. | ||
31 | 00646311550904 | PI02Y23 | PORT ACCESS INFUSION SET | SB-KAWASUMI LABORATORIES, INC. | ||
32 | 00646311550898 | PI02Y03 | PORT ACCESS INFUSION SET | SB-KAWASUMI LABORATORIES, INC. | ||
33 | 00646311550881 | PI02Y93 | PORT ACCESS INFUSION SET | SB-KAWASUMI LABORATORIES, INC. | ||
34 | 00646311550874 | PI03023 | PORT ACCESS INFUSION SET | SB-KAWASUMI LABORATORIES, INC. | ||
35 | 00646311550867 | PI03093 | PORT ACCESS INFUSION SET | SB-KAWASUMI LABORATORIES, INC. | ||
36 | 00646311550850 | PI04023 | PORT ACCESS INFUSION SET | SB-KAWASUMI LABORATORIES, INC. | ||
37 | 00646311550843 | PI04003 | PORT ACCESS INFUSION SET | SB-KAWASUMI LABORATORIES, INC. | ||
38 | 00646311550836 | PI04093 | PORT ACCESS INFUSION SET | SB-KAWASUMI LABORATORIES, INC. | ||
39 | 00646311550812 | PI01Y03 | PORT ACCESS INFUSION SET | SB-KAWASUMI LABORATORIES, INC. | ||
40 | 00646311550799 | PI03003 | PORT ACCESS INFUSION SET | SB-KAWASUMI LABORATORIES, INC. | ||
41 | 00646311550607 | PI05021 | PORT ACCESS INFUSION SET | SB-KAWASUMI LABORATORIES, INC. | ||
42 | 00646311550591 | PI05020 | PORT ACCESS INFUSION SET | SB-KAWASUMI LABORATORIES, INC. | ||
43 | 00646311550584 | PI05001 | PORT ACCESS INFUSION SET | SB-KAWASUMI LABORATORIES, INC. | ||
44 | 00646311550577 | PI05000 | PORT ACCESS INFUSION SET | SB-KAWASUMI LABORATORIES, INC. | ||
45 | 00646311550560 | PI05091 | PORT ACCESS INFUSION SET | SB-KAWASUMI LABORATORIES, INC. | ||
46 | 00646311550553 | PI05090 | PORT ACCESS INFUSION SET | SB-KAWASUMI LABORATORIES, INC. | ||
47 | 00646311550485 | PI01021 | PORT ACCESS INFUSION SET | SB-KAWASUMI LABORATORIES, INC. | ||
48 | 00646311550478 | PI01020 | PORT ACCESS INFUSION SET | SB-KAWASUMI LABORATORIES, INC. | ||
49 | 00646311550461 | PI01001 | PORT ACCESS INFUSION SET | SB-KAWASUMI LABORATORIES, INC. | ||
50 | 00646311550454 | PI01000 | PORT ACCESS INFUSION SET | SB-KAWASUMI LABORATORIES, INC. |