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 | 00304040007488 | 9007027 | 9007027 | Electrode Tab Resting HSI | Henry Schein | HENRY SCHEIN, INC. |
2 | 00304040003367 | 9007028 | 9007028 | ELECTRODE MONITOR HSI | Henry Schein | HENRY SCHEIN, INC. |
3 | B353LP11101 | LP1110 | Biosensor Patch - Electrocardiography Telemetric Monitoring Patch | LifeSignal | LIFESIGNALS, INC. | |
4 | B353IM12101 | IM1210 | Biosensor Patch - Electrocardiography Telemetric Monitoring Patch | ImagineMed | LIFESIGNALS, INC. | |
5 | B353IM11101 | IM1110 | Biosensor Patch - Electrocardiography Telemetric Monitoring Patch | ImagineMIC | LIFESIGNALS, INC. | |
6 | B353CS124501 | CS1245 | Biosensor Patch - Electrocardiography Telemetric Monitoring Patch | Cherish Serenity | LIFESIGNALS, INC. | |
7 | B277299MSTE1 | 292-MSTE | 292-MSTE | Single Tab Electrode, each pouch contains 100 single use gel backed electrodes. | Metagenics Single Tab Electrode | IMPEDIMED LIMITED |
8 | B277292STE1 | 292-STE | 292-STE | Single Tab Electrode, each pouch contains 100 single use gel backed electrodes. | Single Tab Electrode | IMPEDIMED LIMITED |
9 | B277292DTE1 | 292-DTE | 292-DTE | Lymphederma Dual Tab Electrodes; each pouch contains 60 single use gel backed electrodes | Dual Tab Electrode | IMPEDIMED LIMITED |
10 | B277292BCE1 | 292-BCE | 292-BCE | Body Composition Dual Tab Electrode, each pouch contains 60 single use gel backe Body Composition Dual Tab Electrode, each pouch contains 60 single use gel backed electrodes. | Body Composition Dual Tab Electrode | IMPEDIMED LIMITED |
11 | B202925001 | 92500 | 92500P | Package contains 100 adhesive electrodes, sufficient for performing 25 BIA tests Package contains 100 adhesive electrodes, sufficient for performing 25 BIA tests for whole-body body composition analysis. | BIA Electrodes | R.J.L. SCIENCES, INC. |
12 | B146PE30 | 02-01909 | Universal electrode patch | BRAEMAR MANUFACTURING, LLC | ||
13 | B146PE2C0 | 02-01639 | Universal CE electrode-patch | BRAEMAR MANUFACTURING, LLC | ||
14 | B146PE20 | 02-01609 | Universal electrode-patch | BRAEMAR MANUFACTURING, LLC | ||
15 | B146EPE0 | 02-00168 | ePatch Electrode-patch | BRAEMAR MANUFACTURING, LLC | ||
16 | B0361015663 | 1015663 | 1015663 | Smart Trace Electrodes .060 in., 10 Sets of 3 | Smart Trace Electrodes .060 in | CIRCADIANCE, LLC |
17 | B0361015662 | 1015662 | 1015662 | Smart Trace Electrodes .080 in., 20 Pairs | Smart Trace Electrodes .080 in | CIRCADIANCE, LLC |
18 | 80888277352338 | MDSM616201 | MDSM616201 | ELECTRODE,ECG,TAB,10/CARD,5000/CS, ADULT | MEDLINE INDUSTRIES, INC. | MEDLINE INDUSTRIES, INC. |
19 | 80888277352321 | MDSM616101 | MDSM616101 | ELECTRODE,ECG,TAB,10/CARD,5000/CS, SMALL | Medline | MEDLINE INDUSTRIES, INC. |
20 | 80888277181426 | MDSM619350R | MDSM619350R | ELECTRODE,FOAM,WET GEL, RADIOTRANS,50/PK | Medline | MEDLINE INDUSTRIES, INC. |
21 | 80884389830429 | MDSM611805R | MDSM611805R | ELECTRODE,RADIOTRANSLUCENT,FOAM,5PK | Medline | MEDLINE INDUSTRIES, INC. |
22 | 80884389830283 | MDSM611403 | MDSM611403 | ELECTRODE,ECG,CLEAR TAPE,SOLID GEL,3PK | Medline | MEDLINE INDUSTRIES, INC. |
23 | 80813150021520 | Z05SGRT-3NB USA | 6502999V | 3 PER POUCH, 400 POUCHES PER CASE, 1200/CASE | Z-Brand™ | GRAPHIC CONTROLS ACQUISITION CORP |
24 | 80813150021087 | A10072-3 | A10072-3 | PerformancePlus™ | GRAPHIC CONTROLS ACQUISITION CORP | |
25 | 80813150020394 | A10005SG-5NB | A10005SG-5NB | VersaTrode™ | GRAPHIC CONTROLS ACQUISITION CORP | |
26 | 80813150020066 | A10003-4-48 | A10003-4-48 | Pack of 4, 12 packs/ inner box, 6 boxes per outer Case | EMS Electrodes™ | GRAPHIC CONTROLS ACQUISITION CORP |
27 | 70885403287048 | 2009101-404 | 2009101-404 | ECG Electrodes, 55mm Round, Clear Tape, Hydrogel | N/A | CAREFUSION FINLAND 320 OY |
28 | 70885403258901 | 2066867-014 | 2066867-014 | Mactrode™ Wide Mouth Clips for 15-lead | Mactrode | CAREFUSION FINLAND 320 OY |
29 | 70885403256785 | 2066867-010 | 2066867-010 | Mactrode™ Wide Mouth Clips for 12-lead | Mactrode | CAREFUSION FINLAND 320 OY |
30 | 70885403255641 | 91920031 | 91920031 | SilverTRACE™ ECG Electrodes, 55mm Round, Foam, Wet Gel | SilverTRACE | CAREFUSION FINLAND 320 OY |
31 | 70885403253852 | 2014778-001 | 2014778-001 | SilverTRACE™ ECG Electrodes, 44x28mm Rectangular, Foam, Banana Plug, Wet Gel | SilverTRACE | CAREFUSION FINLAND 320 OY |
32 | 70885403253845 | 2014776-001 | 2014776-001 | SilverTRACE™ ECG Electrodes, 44x32mm Rectangular, Foam, Wet Gel | SilverTRACE | CAREFUSION FINLAND 320 OY |
33 | 70885403253838 | 2009110-003 | 2009110-003 | ECG Electrodes, 55mm Round, Foam, Hydrogel | N/A | CAREFUSION FINLAND 320 OY |
34 | 70885403253821 | 2009109-050 | 2009109-050 | ECG Electrodes, 55mm Round, Clear Tape, Hydrogel | N/A | CAREFUSION FINLAND 320 OY |
35 | 70885403253814 | 2009109-005 | 2009109-005 | ECG Electrodes, 55mm Round, Clear Tape, Hydrogel | N/A | CAREFUSION FINLAND 320 OY |
36 | 70885403253579 | 2014785-001 | 2014785-001 | SilverTRACE™ ECG Electrodes, 50mm Round, Vinyl Tape, Solid Gel | SilverTRACE | CAREFUSION FINLAND 320 OY |
37 | 70885403253562 | 2014784-001 | 2014784-001 | SilverTRACE™ ECG Electrodes, 50mm Round, Vinyl Tape, Solid Gel | SilverTRACE | CAREFUSION FINLAND 320 OY |
38 | 70885403253197 | 2014779-001 | 2014779-001 | SilverTRACE™ ECG Electrodes, 55mm Round, Microporous Tape, Wet Gel | SilverTRACE | CAREFUSION FINLAND 320 OY |
39 | 70885403253111 | 2009110-005 | 2009110-005 | ECG Electrodes, 55mm Round, Foam, Hydrogel | N/A | CAREFUSION FINLAND 320 OY |
40 | 70885403252787 | 2014783-001 | 2014783-001 | SilverTRACE™ ECG Electrodes, 50mm Round, Vinyl Tape, Solid Gel | SilverTRACE | CAREFUSION FINLAND 320 OY |
41 | 70885403252770 | 2014782-001 | 2014782-001 | SilverTRACE™ ECG Electrodes, 40mm Round, Cloth, Solid Gel | SilverTRACE | CAREFUSION FINLAND 320 OY |
42 | 70885403252763 | 2014777-001 | 2014777-001 | SilverTRACE™ ECG Electrodes, 55mm Round, Foam, Wet Gel | SilverTRACE | CAREFUSION FINLAND 320 OY |
43 | 70885403252756 | 2014768-001 | 2014768-001 | SilverTRACE™ ECG Electrodes, 35x41mm Oval, Foam, Solid Gel | SilverTRACE | CAREFUSION FINLAND 320 OY |
44 | 70885403252602 | 2009111-050 | 2009111-050 | ECG Electrodes, 55mm Round, Cloth, Hydrogel | N/A | CAREFUSION FINLAND 320 OY |
45 | 70885403252596 | 2009110-150 | 2009110-150 | ECG Electrodes, 43mm Round, Foam, Hydrogel | N/A | CAREFUSION FINLAND 320 OY |
46 | 70885403252589 | 2009110-050W | 2009110-050W | ECG Electrodes, 55mm Round, Foam, Wet Gel | N/A | CAREFUSION FINLAND 320 OY |
47 | 70885403252572 | 2009110-050R | 2009110-050R | ECG Electrodes, 43mm Round, Foam, Radiolucent, Hydrogel | N/A | CAREFUSION FINLAND 320 OY |
48 | 70885403252558 | 2009101-403 | 2009101-403 | ECG Electrodes, 32mm Neonatal Round, Cloth, Radiolucent, Hydrogel | N/A | CAREFUSION FINLAND 320 OY |
49 | 70885403252541 | 2009101-210 | 2009101-210 | Resting ECG Electrodes for 12-lead, Small | N/A | CAREFUSION FINLAND 320 OY |
50 | 70885403252534 | 2009101-003P | 2009101-003P | Resting ECG Electrodes for 12-lead, Extra Adhesive | N/A | CAREFUSION FINLAND 320 OY |