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 | 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 | 04260497026006 | EE-0203 | Narcotrend Electrode | MT MONITORTECHNIK GMBH & CO. KG | ||
2 | EMIP53002030 | large | 5300203 | MRI ECG Electrode 110mm x 110mm | ezPad MRI | MIPM MAMMENDORFER INSTITUT FÜR PHYSIK UND MEDIZIN GMBH |
3 | EMIP53002020 | small | 5300202 | MRI ECG Electrode 70mm x 70mm | ezPad MRI | MIPM MAMMENDORFER INSTITUT FÜR PHYSIK UND MEDIZIN GMBH |
4 | 04049098009270 | 4527750 | ECG Electrodes, Disposable 50 pcs | DRAEGER MEDICAL SYSTEMS, INC. | ||
5 | 03760232460245 | V1 | The HFVI sensor is a disposable, pre-gelled 3-lead array.The HFVI sensor is to b The HFVI sensor is a disposable, pre-gelled 3-lead array.The HFVI sensor is to be usd with the HFVI Pain Monitoring System and may be worn for a continous period of 24 hours in a hospital environment. | HFVI SENSOR V1 | MDOLORIS MEDICAL SYSTEMS | |
6 | 03700506319527 | CLARAVUE PM 12 RT CARDIO | 50602-US-CARDIO | Set of 10 Patient Monitoring ECG Pre Wired Electrodes Radio Translucent for Adult Patients | CLARAVUE | NISSHA MEDICAL TECHNOLOGIES SAS |
7 | 03700506307357 | IP-Set N3-Pediatric-US | 32028776 | SET OF 3 PRE-WIRED PEDIATRIC ELECTRODES | Vermed | GRAPHIC CONTROLS ACQUISITION CORP |
8 | 03700506307340 | IP-Set M3 RT Adult-US | 32028777 | SET OF 3 PRE-WIRED RT ADULT ELECTRODES | Vermed | GRAPHIC CONTROLS ACQUISITION CORP |
9 | 03700506307333 | IP-Set M5 RT Adult-US | 32028778 | SET OF 5 PRE-WIRED RT ADULT ELECTRODES | Vermed | GRAPHIC CONTROLS ACQUISITION CORP |
10 | 03700506307326 | IP-Set 12 RT Adult-US | 32028779 | SET OF 12 PRE-WIRED RT ADULT ELECTRODES | Vermed | GRAPHIC CONTROLS ACQUISITION CORP |
11 | 03700506307319 | IP-Set 6V RT ADULT-US | 32028780 | SET OF 6V PRE-WIRED RT ADULT ELECTRODES | Vermed | GRAPHIC CONTROLS ACQUISITION CORP |
12 | 03700506307302 | IP-Set 5V RT Adult-US | 32028781 | SET OF 5 PRE-WIRED RT ADULT ELECTRODES | Vermed | GRAPHIC CONTROLS ACQUISITION CORP |
13 | 03700506300136 | CLARAVUE PM D12 RT US | 32028779 50602-US | Set of 10 Patient Monitoring ECG Pre Wired Electrodes Radio Translucent for Adult Patients | CLARAVUE | NISSHA MEDICAL TECHNOLOGIES SAS |
14 | 03700506300112 | CLARAVUE PM M5 RT US | 32028778 50601-US | Set of 5 ECG Pre Wired Electrodes Radio Translucent for Adult | Claravue | NISSHA MEDICAL TECHNOLOGIES SAS |
15 | 03700506300013 | CLARAVUE PM NEONAT/PEDIATRIC 3 RT | 32028776 50401-US | Set of 3 Pateint Monitoring ECG Pre Wired Electrodes Radio Translucent for Neona Set of 3 Pateint Monitoring ECG Pre Wired Electrodes Radio Translucent for Neonat/Pediatric Patients | CLARAVUE | NISSHA MEDICAL TECHNOLOGIES SAS |
16 | 03615220001118 | 1005-00008-US | 1005-00008-US | Cardioskin Textile S44 | BIOSERENITY | |
17 | 03615220001101 | 1005-00005-US | 1005-00005-US | Cardioskin Textile S43 | BIOSERENITY | |
18 | 03615220001095 | 1005-00010-US | 1005-00010-US | Cardioskin Textile S42 | BIOSERENITY | |
19 | 03615220001088 | 1005-00004-US | 1005-00004-US | Cardioskin Textile S41 | BIOSERENITY | |
20 | 03615220001071 | 1005-00003-US | 1005-00003-US | Cardioskin textile S34 | BIOSERENITY | |
21 | 03615220001064 | 1005-00002-US | 1005-00002-US | Cardioskin Textile S32 | BIOSERENITY | |
22 | 03615220001057 | 1005-00007-US | 1005-00007-US | Cardioskin Textile S30 | BIOSERENITY | |
23 | 03615220001040 | 1005-00006-US | 1005-00006-US | Cardioskin Textile S24 | BIOSERENITY | |
24 | 03615220001033 | 1005-00001-US | 1005-00001-US | Cardioskin Textile S22 | BIOSERENITY | |
25 | 03615220001026 | 1005-00009-US | 1005-00009-US | Cardioskin Textile S20 | BIOSERENITY | |
26 | 00891893002246 | 10-25; 10-25S; 10-61 | 10-25; 10-25S; 10-61; 10-65 | Single 25g tube of Nuprep Skin Prep Gel (unit of use). | Nuprep Skin Prep Gel | D. O. WEAVER AND COMPANY |
27 | 00891893002215 | 10-30; 10-30K | Single 4oz tube of Nuprep Skin Prep Gel (unit of use) | Nuprep Skin Prep Gel | D. O. WEAVER AND COMPANY | |
28 | 00885380048473 | EPP3CR | EPP3CR | Monitoring Electrode, Neonatal, Prewired, Cloth | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
29 | 00885380048466 | EPP3CL | EPP3CL | Monitoring Electrode, Neonatal, Prewired, Cloth | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
30 | 00885380048459 | EPP3TR | EPP3TR | Monitoring Electrode, Neonatal, Round, Prewired, Clear Tape | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
31 | 00885380048442 | EPP3TL | EPP3TL | Monitoring Electrode, Neonatal, Prewired, Clear Tape | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
32 | 00885380048435 | ERT100HP | ERT100HP | Monitoring Electrode, Resting Tab, Premium | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
33 | 00885380048428 | ERT100LC | ERT100LC | Monitoring Electrode, Resting Tab | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
34 | 00884838013162 | Electrode, limb clamp Icon/C400 4/bx | 989803101691 | Electrode, limb clamp Icon/C400 4/bx | NOUN | PHILIPS MEDICAL SYSTEMS HSG |
35 | 00883873790687 | 11103 | 11103-000037 | ELECTRODES, 5-YEAR, LPCR2, LL | NA | PHYSIO-CONTROL, INC. |
36 | 00869413000201 | CQP-004-RT | Single-use disposable precordial overlay ECG system | CardioQuick Patch | ENNOVEA MEDICAL, LLC | |
37 | 00868795000250 | DELF3000L | DISPOSABLE SNAP ELECTRODE, FOAM/HYDROGEL ADHESIVE | Med-Dyne | MED-DYNE, INC. | |
38 | 00868795000243 | DEL3000I | DISPOSABLE SNAP ELECTRODE, CLOTH/HYDROGEL ADHESIVE | Med-Dyne | MED-DYNE, INC. | |
39 | 00868795000236 | DEL3000A | DEL3000A | Disposable Snap Electrode, cloth/Hydrogel Adhesive - PACK OF 45 | Med-Dyne | MED-DYNE, INC. |
40 | 00868795000229 | DEL3000 | DEL3000 | Disposable Snap Electrode, Cloth/Hydrogel Adhesive - PACK OF 45 | Med-Dyne | MED-DYNE, INC. |
41 | 00867972000250 | BMI GS27 | GS27 Pre-gelled Disposable sEMG Electrodes | GS27 | BIO-MEDICAL INSTRUMENTS, INC. | |
42 | 00865773000370 | SF05 | ECG Electrodes Case - Teardrop | Precision Disposable Products | PRECISION DISPOSABLE PRODUCTS INC | |
43 | 00865773000363 | SF05 | ECG Electrodes Case - Teardrop | Precision Disposable Products | PRECISION DISPOSABLE PRODUCTS INC | |
44 | 00865773000349 | SF22 | ECG Electrodes Case - Square | Precision Disposable Products | PRECISION DISPOSABLE PRODUCTS INC | |
45 | 00865773000332 | SF22 | ECG Electrodes Case - Square | Precision Disposable Products | PRECISION DISPOSABLE PRODUCTS INC | |
46 | 00865773000318 | SF08 | ECG Electrodes Bag - Circle | Precision Disposable Products | PRECISION DISPOSABLE PRODUCTS INC | |
47 | 00865773000301 | SF08 | ECG Electrodes Case - Circle | Precision Disposable Products | PRECISION DISPOSABLE PRODUCTS INC | |
48 | 00863712000306 | AE2403 | Cutaneous sensing electrode - 4-pack | mTrigger | MTRIGGER, LLC | |
49 | 00862795000418 | Large | EKG Glove, a disposable latex glove containing electrodes which when applied to EKG Glove, a disposable latex glove containing electrodes which when applied to the skin, collect data for an EKG - Large size | EKG Glove | INEEDMD HOLDINGS, INC. | |
50 | 00862795000401 | Medium Size | EKG Glove, a disposable latex glove containing electrodes which when applied to EKG Glove, a disposable latex glove containing electrodes which when applied to the skin, collect data for an EKG - Medium size | EKG Glove | INEEDMD HOLDINGS, INC. |