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 | 00190376218809 | 100831 | SafeOp Neural Informatix System Cable, Left stimulator (Blue) | SafeOp | ALPHATEC SPINE, INC. | |
2 | 00190376189154 | 200577-SS | Right stimulator cable | SafeOp | ALPHATEC SPINE, INC. | |
3 | 00190376189147 | 200576-SS | Left stimulator cable | SafeOp | ALPHATEC SPINE, INC. | |
4 | 00190376189130 | 200575-SS | Right acquisition cable | SafeOp | ALPHATEC SPINE, INC. | |
5 | 00190376189123 | 200574-SS | Left acquisition cable | SafeOp | ALPHATEC SPINE, INC. | |
6 | 00190376189116 | 100670 | Stim and Acquisition Cable Kit | SafeOp | ALPHATEC SPINE, INC. | |
7 | 00190376180250 | 200540 | SafeOp Probe and Clip Adapter | SafeOp | ALPHATEC SPINE, INC. | |
8 | 00092237618233 | WQ8110-SNGL | Leadwire | N/A | ROSCOE MEDICAL | |
9 | 00092237617502 | WW8000-TP | Lead Wires for Neo Tek Devices | TENS PROS | COMPASS HEALTH BRANDS CORP. | |
10 | 00092237617496 | WW7360 | Church Key Lead Wire style | N/A | COMPASS HEALTH BRANDS CORP. | |
11 | 00092237617472 | WW6012 | UltraTENS II Leadwire - Single | N/A | COMPASS HEALTH BRANDS CORP. | |
12 | 00092237617465 | WW6000 | TOP TENS White Lead Wires | N/A | COMPASS HEALTH BRANDS CORP. | |
13 | 00092237617458 | WW5000 | 5 Foot Lead Wire(2 per pkg) | N/A | COMPASS HEALTH BRANDS CORP. | |
14 | 00092237617441 | WW4488 | IF 4K Lead Wires, one pair | N/A | COMPASS HEALTH BRANDS CORP. | |
15 | 00092237617434 | WW4394 | Mini TENS Lead Wire w/ Snaps | N/A | COMPASS HEALTH BRANDS CORP. | |
16 | 00092237617427 | WW4150 | Mini TENS Lead Wire for Pin | N/A | COMPASS HEALTH BRANDS CORP. | |
17 | 00092237617410 | WW3766 | Lead Wire Extender | N/A | COMPASS HEALTH BRANDS CORP. | |
18 | 00092237617403 | WW1001PLUG | Combination Lead Wire for | N/A | COMPASS HEALTH BRANDS CORP. | |
19 | 00092237617397 | WW1001 | Combination Lead Wire for | N/A | COMPASS HEALTH BRANDS CORP. | |
20 | 00092237617380 | WQ8110 | CX4 & EX4 Clinical Leadwires | N/A | ROSCOE MEDICAL | |
21 | 00092237617373 | WQ8000-SNGL | 78 Single (Combination) Lead | N/A | ROSCOE MEDICAL | |
22 | 00092237617366 | WQ8000 | 78 Clinical Lead Wires | N/A | ROSCOE MEDICAL | |
23 | 00092237617342 | WQ6005PLUG | Lead Wires for Quattro 2/2.5 & | N/A | ROSCOE MEDICAL | |
24 | 00092237617335 | WQ1010 | Quattro Lead Wires - 10 Foot | N/A | COMPASS HEALTH BRANDS CORP. | |
25 | 00092233761742 | WW1001PLUG | Combination Lead Wire for | N/A | COMPASS HEALTH BRANDS CORP. | |
26 | B631TCPH2HP123M1 | TCPH2HP123M | SureLead | AUTHENTIC MEDICAL | ||
27 | B631DLSPHP5PE9F1 | DLSPHP5PE9F | SureLead | AUTHENTIC MEDICAL | ||
28 | B631DLSGPHP5PE9F1 | DLSGPHP5PE9F | SureLead | AUTHENTIC MEDICAL | ||
29 | B631ADMX2PH51 | ADMX2PH5 | Surelead | AUTHENTIC MEDICAL | ||
30 | B312W234060 | W23406 | Two conductor bonded 2.5 mm straight female jack to 0.08" socket, 6" lead wire | C.M.P. Cable | C.M.P. CANADIAN MEDICAL PRODUCTS INC | |
31 | B312W232180 | W23218 | Dual female 0.08" socket to single male 0.08" pin, 18" lead wire | C.M.P. Cable | C.M.P. CANADIAN MEDICAL PRODUCTS INC | |
32 | B312W23120 | W2312 | 3-Pin Amphenol (with coupler) to Dual Pins 120" lead wire | C.M.P. Cable | C.M.P. CANADIAN MEDICAL PRODUCTS INC | |
33 | B312W231180 | W23118 | Two conductor bonded bifurcated male banana to dual female banana, 18" lead wire | C.M.P. Cable | C.M.P. CANADIAN MEDICAL PRODUCTS INC | |
34 | B312W99060 | W9906 | Single 0.080" Socket to Banana Plug Wire Converter 6" lead wire | C.M.P. Cable | C.M.P. CANADIAN MEDICAL PRODUCTS INC | |
35 | B312W98720 | W9872 | Dual Female 0.08" sockets to dual 0.08" pins, 72" lead wire | C.M.P. Cable | C.M.P. CANADIAN MEDICAL PRODUCTS INC | |
36 | B312W98480 | W9848 | 48" Dual Female 0.080" PIN to Dual Male 0.080" PIN lead wire | C.M.P. Cable | C.M.P. CANADIAN MEDICAL PRODUCTS INC | |
37 | B312W96720 | W9672 | Single 0.080" Socket to 0.080" Pin Wire Extender 72" lead wire | C.M.P. Cable | C.M.P. CANADIAN MEDICAL PRODUCTS INC | |
38 | B312W96180 | W9618 | Single 0.080" Socket to 0.080" Pin Wire Extender 18" lead wire | C.M.P. Cable | C.M.P. CANADIAN MEDICAL PRODUCTS INC | |
39 | B312W96060 | W9606 | Regular 0.08" socket to 0.08" pin, 6" lead wire | C.M.P. Cable | C.M.P. CANADIAN MEDICAL PRODUCTS INC | |
40 | B312W95060 | W9506 | Pin to Snap Wire Converter 6" lead wire | C.M.P. Cable | C.M.P. CANADIAN MEDICAL PRODUCTS INC | |
41 | B312W94180 | W9418 | Banana - Pin Wire Converter 18" lead wire | C.M.P. Cable | C.M.P. CANADIAN MEDICAL PRODUCTS INC | |
42 | B312W93180 | W9318 | Bifurcated Lead Female Pin - Dual Pins 18" lead wire | C.M.P. Cable | C.M.P. CANADIAN MEDICAL PRODUCTS INC | |
43 | B312W92720 | W9272 | Bifurcated Lead Female Pin - Dual Pins 72" lead wire | C.M.P. Cable | C.M.P. CANADIAN MEDICAL PRODUCTS INC | |
44 | B312W92180 | W9218 | Bifurcated Lead Female Pin - Dual Pins 18" lead wire | C.M.P. Cable | C.M.P. CANADIAN MEDICAL PRODUCTS INC | |
45 | B312W921180 | W92118 | Bifurcated Female 0.08" socket to dual bananas, 18" lead wire | C.M.P. Cable | C.M.P. CANADIAN MEDICAL PRODUCTS INC | |
46 | B312W912180 | W91218 | Bifurcated Female Banana to dual 0.08" pins, 18" lead wire | C.M.P. Cable | C.M.P. CANADIAN MEDICAL PRODUCTS INC | |
47 | B312W91180 | W9118 | Bifurcated Lead Female Banana - Dual Bananas 18" lead wire | C.M.P. Cable | C.M.P. CANADIAN MEDICAL PRODUCTS INC | |
48 | B312W89720 | W8972 | Straight Mini 3-Pin DIN to Dual Pins 72" lead wire | C.M.P. Cable | C.M.P. CANADIAN MEDICAL PRODUCTS INC | |
49 | B312W88600 | W8860 | Mini 3 Pin DIN to 3 Pins lead wire | C.M.P. Cable | C.M.P. CANADIAN MEDICAL PRODUCTS INC | |
50 | B312W87720 | W8772 | Straight DIN 3 Pin to Single Pin 72" lead wire -Combo | C.M.P. Cable | C.M.P. CANADIAN MEDICAL PRODUCTS INC |