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 | B146C6R20 | 02-01897 | DSI | Detector And Alarm, Arrhythmia | 2 | C6 Sensor 2.0 rebuilt | ||
6 | B146C6D10 | 02-01606 | DSI | Detector And Alarm, Arrhythmia | 2 | C6 Sensor | ||
7 | B146C5M20 | 02-00116 | DSI | Detector And Alarm, Arrhythmia | 2 | C5 Monitor NOBT | ||
8 | B146PERP0 | 900-0553-06 | ENHANCED ALGORITHM ECG EVENT RECORDER | MWJ | Electrocardiograph,Ambulatory(Without Analysis) | 2 | PER900 Preventice | |
9 | B146PE2C0 | 02-01639 | DRX | Electrode, Electrocardiograph | 2 | Universal CE electrode-patch | ||
10 | B146FUSFCM0 | 900-0584-50 | Wireless Ambulatory ECG Arrhythmia Monitoring system | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | Fusion First Call Medical | |
11 | B146ERW3G030 | 900-0614-03 | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | ER9W 3GSM Life Support | ||
12 | B146ER9WLS0 | 900-0581-44 | Wireless Arrhythmia Event Recorder | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | ER920W Life Support | |
13 | B146ER9WFCM0 | 900-0581-57 | Wireless Arrhythmia Event Recorder | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | ER920W First-Call Medical | |
14 | B146ER9WCL0 | 900-0581-58 | Wireless Arrhythmia Event Recorder | DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | ER920W CardioLabs | |
15 | B146EPE30 | 390-0240-02 | IKD | Cable, Electrode | ePatch electrode-patch | |||
16 | B146EP2R10 | 02-01997 | DSH | Recorder, Magnetic Tape, Medical | 2 | ePatch 2.0 rebuilt | ||
17 | B146EP2020 | 02-01650 | DSH | Recorder, Magnetic Tape, Medical | 2 | ePatch 2.0 BTI | ||
18 | B146EP080 | 900-0632-05 | DSH | Recorder, Magnetic Tape, Medical | 2 | Epatch Sensor | ||
19 | B146EP070 | 900-0632-04 | DSH | Recorder, Magnetic Tape, Medical | 2 | Epatch Sensor | ||
20 | B146EP060 | 900-0632-03 | 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 | 00840067101230 | 302204-200 | Cable, Reusable Shielded Mono with Pin | Cadwell Shielded Cable | CADWELL INDUSTRIES, INC. | |
2 | 00840067101223 | 302192-200 | Cable, Shield Interconn, 48" Grey | Cadwell Shielded Interconnect Cable | CADWELL INDUSTRIES, INC. | |
3 | 00840067101216 | 302176-200 | Cable, Shield Interconn, 18", Grey | Cadwell Shielded Interconnect Cable | CADWELL INDUSTRIES, INC. | |
4 | 00840067102855 | 199313-200 | Summit Headphones Adapter | Sierra Summit | CADWELL INDUSTRIES, INC. | |
5 | 00840067102640 | 198263-200 | 16-Input Tech Attach Zenect Cable | Cadwell Lead Wire | CADWELL INDUSTRIES, INC. | |
6 | 00840067102633 | 198262-200 | 12-Input Tech Attach Zenect Cable | Cadwell Lead Wire | CADWELL INDUSTRIES, INC. | |
7 | 00840067102626 | 198261-200 | 8-Input Tech Attach Zenect Cable | Cadwell Lead Wire | CADWELL INDUSTRIES, INC. | |
8 | 00840067102619 | 198260-200 | 16-Input Cabrio Zenect Cable | Cadwell Lead Wire | CADWELL INDUSTRIES, INC. | |
9 | 00840067102602 | 198259-200 | 12-Input Cabrio Zenect Cable | Cadwell Lead Wire | CADWELL INDUSTRIES, INC. | |
10 | 00840067102596 | 198258-200 | 8-Input Cabrio Zenect Cable | Cadwell Lead Wire | CADWELL INDUSTRIES, INC. | |
11 | 00840067102589 | 202449-200-010 | Lead, Keyhole, Touchprf 10 in BLK-BLU | Cadwell Lead-Wire | CADWELL INDUSTRIES, INC. | |
12 | 00840067102572 | 202448-200-020 | Lead, Keyhole, TP 20IN BLK-YLW | Cadwell Lead-Wire | CADWELL INDUSTRIES, INC. | |
13 | 00840067102558 | 302785-200 | Cable, Intrcont Twtd TP-TP 24 Inch Black & Red | Cadwell Interconnect Cable | CADWELL INDUSTRIES, INC. | |
14 | 00840067102541 | 302151-200 | Stim Probe Extension Kit | Cadwell Probe Extension Kit | CADWELL INDUSTRIES, INC. | |
15 | 00840067102534 | 362052-200 | Stim Probe Extension | Cadwell Stim Probe | CADWELL INDUSTRIES, INC. | |
16 | 00840067102466 | 302313-200 | Electrode, Snap Multicolor/Black Twstd Pair 5PK | Cadwell Patch Electrode with Snap Connector | CADWELL INDUSTRIES, INC. | |
17 | 00840067102459 | 302312-200 | Electrode, Snap Multicolor/White Twstd Pair 5PK | Cadwell Patch Electrode with Snap Connector | CADWELL INDUSTRIES, INC. | |
18 | 00840067102411 | 302300-200-060 | Electrode Leadwire w/Flat Snap Amb 152cm/60in 4/Pk | Cadwell Patch Electrode with Snap Connector | CADWELL INDUSTRIES, INC. | |
19 | 00840067102404 | 302300-200-024 | Electrode Leadwire w/Flat Snap Amb 61cm/24in 11/Pk | Cadwell Patch Electrode with Snap Connector | CADWELL INDUSTRIES, INC. | |
20 | 00840067102381 | 302227-200 | Crocodile Clip Kit, Twisted | Cadwell Mini-Crocodile Clip Lead Wire | CADWELL INDUSTRIES, INC. | |
21 | 00840067102374 | 302253-200 | Crocodile Clip, Kit 30 in | Cadwell Mini-Crocodile Clip Lead Wire | CADWELL INDUSTRIES, INC. | |
22 | 00840067102367 | 302251-200 | Crocodile Clip, Ea 30 in Black | Cadwell Mini-Crocodile Clip Lead Wire | CADWELL INDUSTRIES, INC. | |
23 | 00840067102350 | 302250-200 | Crocodile Clip 30in Red | Cadwell Mini-Crocodile Clip Lead Wire | CADWELL INDUSTRIES, INC. | |
24 | 00840067102343 | 302228-200 | Quick Connect, TP Twist 8"-20cm 2PK | Cadwell Quick Connect Adapter | CADWELL INDUSTRIES, INC. | |
25 | 00840067102336 | 302226-200 | Crocodile Clip Kit - 3/Pkg 48 in | Cadwell Mini-Crocodile Clip Lead Wire | CADWELL INDUSTRIES, INC. | |
26 | 00840067102329 | 302225-200 | Crocodile Clip Kit - 3/Pkg 18 in | Cadwell Mini-Crocodile Clip Lead Wire | CADWELL INDUSTRIES, INC. | |
27 | 00840067102312 | 302194-200 | Grey Amp Adaptor | Cadwell Amplifier Adapter | CADWELL INDUSTRIES, INC. | |
28 | 00840067102299 | 302144-200 | Amp & Stim White Adaptor | Cadwell Amplifier Adapter | CADWELL INDUSTRIES, INC. | |
29 | 00840067102169 | 302771-200 | 5 Pin DIN Cable Adapter | Cadwell DIN Cable Adapter | CADWELL INDUSTRIES, INC. | |
30 | 00840067102145 | 302774-200 | Elec, Ext Dual Lead Wire | Cadwell Lead Wire | CADWELL INDUSTRIES, INC. | |
31 | 00840067102138 | 302774-200-180 | Elec, Ext Dual Lead Wire 180in/4.6m | Cadwell Lead Wire | CADWELL INDUSTRIES, INC. | |
32 | 00840067102121 | 302781-200 | Quad Extension | Cadwell Lead Wire | CADWELL INDUSTRIES, INC. | |
33 | 00840067101353 | 302252-200 | Croc Clip, 30in Green | Cadwell Crocodile Clip | CADWELL INDUSTRIES, INC. | |
34 | 00840067101193 | 302169-200 | Reference Jumper, Black-Blue 8in | Cadwell Jumper Cable | CADWELL INDUSTRIES, INC. | |
35 | 00840067101186 | 302167-200 | Reference Jumper Cable, 98in/249cm Red | Cadwell Jumper Cable | CADWELL INDUSTRIES, INC. | |
36 | 00840067101179 | 302152-200 | Cable Ext, 5-Port Yoke, 25' | Cadwell Replacement Remote Input Extender Pod | CADWELL INDUSTRIES, INC. | |
37 | 00840067101094 | 302160-200 | Croc Clip Pair, Twisted Red/Black | Cadwell Mini-Crocodile Clip Lead Wire | CADWELL INDUSTRIES, INC. | |
38 | 00840067101056 | 302137-200 | Blue Lead Extender 183cm/72in | Cadwell Extension Lead Wire | CADWELL INDUSTRIES, INC. | |
39 | 00840067101018 | 302131-200 | Lead, Ext Green 122cm/48 in | Cadwell Extension Lead Wire | CADWELL INDUSTRIES, INC. | |
40 | 00840067101001 | 302130-200 | Lead, Ext Black 122cm/48 in | Cadwell Extension Lead Wire | CADWELL INDUSTRIES, INC. | |
41 | 00840067100998 | 302129-200 | Lead, Ext Red 122cm/48 in | Cadwell Extension Lead Wire | CADWELL INDUSTRIES, INC. | |
42 | 00840067100981 | 302128-200 | Croc Clip Ea 48 in Green | Cadwell Mini-Crocodile Clip Lead Wire | CADWELL INDUSTRIES, INC. | |
43 | 00840067100974 | 302127-200 | Croc Clip Ea 18 in Green | Cadwell Mini-Crocodile Clip Lead Wire | CADWELL INDUSTRIES, INC. | |
44 | 00840067100967 | 302126-200 | Croc Clip Ea 48 in Blk | Cadwell Crocodile Clip | CADWELL INDUSTRIES, INC. | |
45 | 00840067100950 | 302125-200 | Croc Clip Ea 18 in Black | Cadwell Mini-Crocodile Clip Lead Wire | CADWELL INDUSTRIES, INC. | |
46 | 00840067100943 | 302124-200 | Croc Clip Ea 48 in Red | Cadwell Mini-Crocodile Clip Lead Wire | CADWELL INDUSTRIES, INC. | |
47 | 00840067100936 | 302123-200 | CROC CLIP EA 18 IN RED | Cadwell Mini-Crocodile Clip Lead Wire | CADWELL INDUSTRIES, INC. | |
48 | 00840067100752 | 199252-200 | Cascade Remote Input Extender Pods, Quickconnect, 6 Meter | Cascade Extender Pod | CADWELL INDUSTRIES, INC. | |
49 | 00840067100745 | 199251-200 | Cascade Remote Input Extender Pods, Quickconnect, 3 Meter | Cascade Extender Pod | CADWELL INDUSTRIES, INC. | |
50 | 00840067100318 | 302773-200 | Cadwell Clip-On Lead Wire | CADWELL INDUSTRIES, INC. |