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 | 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 | 30653405017756 | D8324 | D8324 | CABLE:SHLD;3LD,CONN 3 | CONMED | CONMED CORPORATION |
2 | 30653405006668 | 38-468-1 | 38-468-1 | ECG MONITOR CABLE | NA | CONMED CORPORATION |
3 | 30653405017060 | D8036 | D8036 | CABLE:SHLD;10LD,CONN 48 | CONMED | CONMED CORPORATION |
4 | 30653405015837 | ACP | ACP | ECG Leadwires | NA | CONMED CORPORATION |
5 | 30653405015806 | ACB | ACB | ECG Leadwires | NA | CONMED CORPORATION |
6 | 30653405006811 | 38-620-R | 38-620-R | ECG Leadwires | NA | CONMED CORPORATION |
7 | 30653405006804 | 38-610-H | 38-610-H | ECG Leadwires | NA | CONMED CORPORATION |
8 | 30653405006798 | 38-495-5 | 38-495-5 | ECG MONITOR CABLE | NA | CONMED CORPORATION |
9 | 30653405006781 | 38-495-4 | 38-495-4 | ECG MONITOR CABLE | NA | CONMED CORPORATION |
10 | 30653405006774 | 38-495-1 | 38-495-1 | ECG MONITOR CABLE | NA | CONMED CORPORATION |
11 | 30653405006613 | 38-464-5 | 38-464-5 | ECG MONITOR CABLE | NA | CONMED CORPORATION |
12 | 30653405006552 | 38-460-5 | 38-460-5 | ECG MONITOR CABLE | NA | CONMED CORPORATION |
13 | 30653405000017 | R323II | R323II | CABLE:SAFTEY;3LD; DATASCOPE PASSPORT V | CONMED | CONMED CORPORATION |
14 | 20885380189323 | 33560 | 33560 | Kendall DL Adapter, 5 Lead, For Mindray TD60/TM80 Systems, Telemetry, Reusable, Kendall DL Adapter, 5 Lead, For Mindray TD60/TM80 Systems, Telemetry, Reusable, Non-sterile | Kendall | CARDINAL HEALTH 200, LLC |
15 | 20885380189316 | 33559 | 33559 | Kendall DL Adapter, 3 Lead, For Mindray TD60/TM80 Systems, Telemetry, Reusable, Kendall DL Adapter, 3 Lead, For Mindray TD60/TM80 Systems, Telemetry, Reusable, Non-sterile | Kendall | CARDINAL HEALTH 200, LLC |
16 | 20885380189309 | 33558 | 33558 | Kendall DL Adapter, 3/5 Lead, For Mindray Datascope Monitors, Bedside, Reusable | Kendall | CARDINAL HEALTH 200, LLC |
17 | 20885380189286 | 33556 | 33556 | Kendall DL Adapter, 3/5 Lead, For Mindray Benevision Monitors, OR, Bedside, Reus Kendall DL Adapter, 3/5 Lead, For Mindray Benevision Monitors, OR, Bedside, Reusable, Non-sterile | Kendall | CARDINAL HEALTH 200, LLC |
18 | 20885380189279 | 33555 | 33555 | Kendall DL Adapter, 3/5 Lead, For Mindray Benevision Monitors, Bedside, Reusable Kendall DL Adapter, 3/5 Lead, For Mindray Benevision Monitors, Bedside, Reusable, Non-sterile | Kendall | CARDINAL HEALTH 200, LLC |
19 | 20885380189262 | 33561 | 33561 | Kendall DL Adapter, 10 Lead, For Philips Intellivue Monitors, Reusable, Non-sterile | Kendall | CARDINAL HEALTH 200, LLC |
20 | 20885380171045 | 33548 | 33548 | Kendall DL Adapter for Nihon Kohden monitors, 6-lead, Reusable | Kendall | CARDINAL HEALTH 200, LLC |
21 | 20884527021816 | 33145 | 33145 | DL Disposable Cable,5 Lead Dual Connect | kendall | CARDINAL HEALTH, INC. |
22 | 20884527021809 | 33136 | 33136 | DL Disposable Lead Set,5 Lead Dual Connect | Kendall | CARDINAL HEALTH, INC. |
23 | 20884527021595 | 33525 | 33525 | True content to be populated as part of rebranding | Kendall | CARDINAL HEALTH, INC. |
24 | 20884527021588 | 33523 | 33523 | True content to be populated as part of rebranding | Kendall | CARDINAL HEALTH, INC. |
25 | 20884527021571 | 33522 | 33522 | True content to be populated as part of rebranding | Kendall | CARDINAL HEALTH, INC. |
26 | 20884527021564 | 33521 | 33521 | True content to be populated as part of rebranding | Kendall | CARDINAL HEALTH, INC. |
27 | 20884527021557 | 33520 | 33520 | True content to be populated as part of rebranding | Kendall | CARDINAL HEALTH, INC. |
28 | 20884527021540 | 33519 | 33519 | True content to be populated as part of rebranding | Kendall | CARDINAL HEALTH, INC. |
29 | 20884527021533 | 33518 | 33518 | DL Adapter,5 Lead | Kendall | CARDINAL HEALTH, INC. |
30 | 20884527021526 | 33512 | 33512 | True content to be populated as part of rebranding | Kendall | CARDINAL HEALTH, INC. |
31 | 20884527021519 | 33511 | 33511 | True content to be populated as part of rebranding | Kendall | CARDINAL HEALTH, INC. |
32 | 20884527021410 | 33501 | 33501 | DL 6 Pin Adapter,3 Lead (1316), No Resistors | Kendall | CARDINAL HEALTH, INC. |
33 | 20884527021403 | 33500 | 33500 | DL 6 Pin Adapter,5 Lead, No Resistors | Kendall | CARDINAL HEALTH, INC. |
34 | 20884521531687 | 33528 | 33528 | DL Adapter 12 Lead | Kendall | CARDINAL HEALTH, INC. |
35 | 20884521531670 | 33527 | 33527 | DL Adapter 5 Lead | Kendall | CARDINAL HEALTH, INC. |
36 | 20884521527444 | 33149 | 33149 | DL Disposable Lead System 5 Lead, SpO2 Compatible | Kendall | CARDINAL HEALTH, INC. |
37 | 20884521516431 | 33145R | 33145R | THERMAL TRANSFER PAPER, ACRYLIC PERMANENT, 40# WHITE KRAFT LINER | Kendall | CARDINAL HEALTH, INC. |
38 | 20884521208480 | 33538 | 33538 | DL Adapter, 5 Lead | Kendall | CARDINAL HEALTH, INC. |
39 | 20884521149066 | MW05050A | MW05050A | Cable;2355-36S90R 3 Lead One Piece Cable | Kendall | CARDINAL HEALTH, INC. |
40 | 20884521149059 | MW05025A | MW05025A | Cable;2355-36S 3 Lead One Piece Cable | Kendall | CARDINAL HEALTH, INC. |
41 | 20884521149042 | MW05000A | MW05000A | Cable;2320-S 3 Lead One Piece Cable | Kendall | CARDINAL HEALTH, INC. |
42 | 20884521149028 | 50000278A | 50000278A | Lead Wires;SL-11362 Pinch, 0.080� (0.2 cm) Socket, Black, White | Kendall | CARDINAL HEALTH, INC. |
43 | 20884521149011 | 50000224A | 50000224A | Lead Wires;SL-3A1362 Snap, 0.080� (0.2 cm) Socket, Black, White | Kendall | CARDINAL HEALTH, INC. |
44 | 20884521149004 | 31287751A | 31287751A | Cable;D-1585 5 Lead DIN | Kendall | CARDINAL HEALTH, INC. |
45 | 20884521148991 | 31287363A | 31287363A | Cable;D-1540 5 Lead DIN | Kendall | CARDINAL HEALTH, INC. |
46 | 20884521148984 | 31286548A | 31286548A | Cable;D-1393 3 Lead DIN | Kendall | CARDINAL HEALTH, INC. |
47 | 20884521148977 | 31286498A | 31286498A | Cable;D-1385 3 Lead DIN, 12 Pin | Kendall | CARDINAL HEALTH, INC. |
48 | 20884521148960 | 31286084A | 31286084A | Cable;D-1340 3 Lead ECG with Connector, 6 Pin DIN | Kendall | CARDINAL HEALTH, INC. |
49 | 20884521148953 | 31285888A | 31285888A | Cable;D-1316 3 Lead DIN | Kendall | CARDINAL HEALTH, INC. |
50 | 20884521148946 | 31285532A | 31285532A | Cable;AA-2585 ECG 5 Lead with Connector, 12 Pin | Kendall | CARDINAL HEALTH, INC. |