No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00850010298030 | EAS | The Eko Analysis Software is intended to provide support to the physician in the The Eko Analysis Software is intended to provide support to the physician in the evaluation of patients' heart soundsand ECG’s. The software analyzes simultaneous ECG and heart sounds. The software will detect the presence ofsuspected murmurs in the heart sounds. The software also detects the presence of atrial fibrillation and normalsinus rhythm from the ECG signal. In addition, it calculates certain cardiac time intervals such as heart rate, QRSduration and EMAT. The software does not distinguish between different kinds of murmurs and does not identifyother arrhythmias.It is not intended as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the softwareare only significant when used in conjunction with physician over-read and is for use on adults (> 18 years) | MWI,DPS,DQD | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms),Electro Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms),Electrocardiograph,Stethoscope, Electronic | 2 | Eko Analysis Software | |
2 | 00850010298061 | com.ekodevices.android.intl | Eko mobile app for android international platforms for use with Eko medical devices. | OUG | Medical Device Data System | 1 | Eko Mobile App Android International | |
3 | 00850010298016 | E6 | The Eko Core Electronic Stethoscope is a complete electronic stethoscope with di The Eko Core Electronic Stethoscope is a complete electronic stethoscope with digital & analog capabilities that wirelessly pairs to the free Eko Mobile App for recording, visualization, sharing, and annotation of sounds. | DQD | Stethoscope, Electronic | 2 | Eko Core Digital Stethoscope | |
4 | 00850010298009 | E6 | The Eko Core Attachment connects to (and digitizes) the analog stethoscope you a The Eko Core Attachment connects to (and digitizes) the analog stethoscope you already own. It attaches to almost all single-tubed stethoscopes including LittmannTM, Welch AllynTM, MDFTM, and ADCTM. The Eko Core Attachment wirelessly pairs to the free Eko mobile app for recording, visualization, sharing, and annotation of sounds. | DQD | Stethoscope, Electronic | 2 | Eko Core Digital Attachment | |
5 | 00863609000334 | 3.1.1 | iOS mobile device software for use with Eko products. | OUG | Medical Device Data System | 1 | Eko Mobile App iOS | |
6 | 00863609000303 | Model E4 | The Eko Core Electronic Stethoscope is a complete electronic stethoscope with di The Eko Core Electronic Stethoscope is a complete electronic stethoscope with digital & analog capabilities that wirelessly pairs to the free Eko Mobile App for recording, visualization, sharing, and annotation of sounds. | DQD | Stethoscope, Electronic | 2 | Eko Core Electronic Stethoscope | |
7 | 00863609000341 | 1.2.9 | Eko mobile app for Android platforms for use with Eko products. | OUG | Medical Device Data System | 1 | Eko Mobile App Android | |
8 | 00863609000358 | 1.2.4 | Windows PC Application for use with Eko products. | OUG | Medical Device Data System | 1 | Eko App Windows | |
9 | 00863609000310 | Model E4 | The Eko Core Attachment connects to (and digitizes) the analog stethoscope you a The Eko Core Attachment connects to (and digitizes) the analog stethoscope you already own. It attaches to almost all single-tubed stethoscopes including LittmannTM, Welch AllynTM, MDFTM, and ADCTM. The Eko Core Attachment wirelessly pairs to the free Eko mobile app for recording, visualization, sharing, and annotation of sounds. | DQD | Stethoscope, Electronic | 2 | Eko Core Attachment |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00818323029789 | DMD1030 | ECG Monitor | VIVE | VIVE HEALTH LLC | |
2 | 00817655023311 | 901127 | RSCRIBE-6AC-XXCAA | RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software C RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; Suction electrodes (6) and clamps (4); AHA 10 wire, 12-lead lead set with banana plugs; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing) | Welch Allyn, Inc. | WELCH ALLYN, INC. |
3 | 00817655023267 | 901147 | 107420 | Software Eli Edit Standard | Welch Allyn, Inc. | WELCH ALLYN, INC. |
4 | 00817655023250 | 901147 | 107422 | Software Eli Edit Pro | Welch Allyn, Inc. | WELCH ALLYN, INC. |
5 | 00817655023212 | ELI250c-EAA-ABCAX | Electrocardiograph | ELI 250c | MORTARA INSTRUMENT, INC. | |
6 | 00817655023182 | QS-6AA-CDEAA | Cardiac Stress Testing System | Q-Stress | MORTARA INSTRUMENT, INC. | |
7 | 00817655023168 | ELI250c-EAA-ABCBX | Electrocardiograph | ELI 250c | MORTARA INSTRUMENT, INC. | |
8 | 00817655023151 | 901006 | 34000-025-1004 | Z200+ Thermal printer in cool gray with 8.5 in. x 11 in. paper and accessories. | Welch Allyn, Inc. | WELCH ALLYN, INC. |
9 | 00817655023144 | ELI150c-AAA-ADGBX | Electrocardiograph | ELI 150c | MORTARA INSTRUMENT, INC. | |
10 | 00817655023137 | 9293-048-65 | Wired Acquisition System cleared with the ELI 230 Electrocardiograph | AM12 | MORTARA INSTRUMENT, INC. | |
11 | 00817655023090 | 901095 | 30012-019-76 | Connex Cardio WAM ECG acquisition module v2, without lead wires, for use with Co Connex Cardio WAM ECG acquisition module v2, without lead wires, for use with Connex Cardio | Welch Allyn, Inc. | WELCH ALLYN, INC. |
12 | 00817655023083 | ELI250c-CAC-BCAAX | Electrocardiograph | ELI 250c | MORTARA INSTRUMENT, INC. | |
13 | 00817655023076 | RSCRIBE-6AC-XXAAA | Electrocardiograph | RScribe | MORTARA INSTRUMENT, INC. | |
14 | 00817655023069 | RSCRIBE-7CC-XXBAA | Electrocardiograph | RScribe | MORTARA INSTRUMENT, INC. | |
15 | 00817655023021 | RSCRIBE-6CC-AXCAA | Electrocardiograph | RScribe | MORTARA INSTRUMENT, INC. | |
16 | 00817655023014 | ELI250c-CAA-AACBX | Electrocardiograph | ELI 250c | MORTARA INSTRUMENT, INC. | |
17 | 00817655023007 | ELI150c-AAA-ABAAX | Electrocardiograph | ELI 150c | MORTARA INSTRUMENT, INC. | |
18 | 00817655022994 | ELI150c-GEA-ABCBX | Electrocardiograph | ELI 150c | MORTARA INSTRUMENT, INC. | |
19 | 00817655022987 | ELI150c-CAA-AAAAX | Electrocardiograph | ELI 150c | MORTARA INSTRUMENT, INC. | |
20 | 00817655022963 | ELI250c-MAA-ABCBX | Electrocardiograph | ELI 250c | MORTARA INSTRUMENT, INC. | |
21 | 00817655022888 | RSCRIBE-6AC-XXCAX | Electrocardiograph | RScribe | MORTARA INSTRUMENT, INC. | |
22 | 00817655022871 | ELI250c-AAA-ACCBX | Electrocardiograph | ELI 250c | MORTARA INSTRUMENT, INC. | |
23 | 00817655022864 | ELI250c-CAA-ACCBX | Electrocardiograph | ELI 250c | MORTARA INSTRUMENT, INC. | |
24 | 00817655022802 | 11049-011-51 | Cardiology Data Software | ELI Edit | MORTARA INSTRUMENT, INC. | |
25 | 00817655022796 | 11049-011-50 | Cardiology Data Software | ELI Edit | MORTARA INSTRUMENT, INC. | |
26 | 00817655022789 | ELI280-CAA-ACFBX | Electrocardiograph | ELI 280 | MORTARA INSTRUMENT, INC. | |
27 | 00817655022758 | ELI250c-EDA-ABCAX | Electrocardiograph | ELI 250c | MORTARA INSTRUMENT, INC. | |
28 | 00817655022741 | 41000-038-50 | Wireless Acquisition System cleared with the ELI 230 Electrocardiograph | WAM | MORTARA INSTRUMENT, INC. | |
29 | 00817655022659 | ELI150c-CAA-ABHBX | Electrocardiograph | ELI 150c | MORTARA INSTRUMENT, INC. | |
30 | 00817655022628 | 901128 | CC-RXX-AAXX | Connex Cardio PC based 12-Lead Multi-Channel Resting ECG - software, Connex Card Connex Cardio PC based 12-Lead Multi-Channel Resting ECG - software, Connex Cardio AM12 wired acquisition module, AHA 10 wire, 12-lead lead set with banana plugs, CardioSens Ultra II resting tab electrodes (pouch of 100), Clear Choice adapter clips (set of 10) | Welch Allyn, Inc. | WELCH ALLYN, INC. |
31 | 00817655022611 | 901128 | CC-RXX-AADX | Connex Cardio PC based 12-Lead Multi-Channel Resting ECG - software, Connex Card Connex Cardio PC based 12-Lead Multi-Channel Resting ECG - software, Connex Cardio AM12 wired acquisition module, AHA 10 wire, 12-lead lead set with banana plugs, CardioSens Ultra II resting tab electrodes (pouch of 100), Clear Choice adapter clips (set of 10), DICOM | Welch Allyn, Inc. | WELCH ALLYN, INC. |
32 | 00817655022604 | 901128 | CC-RXX-WAXX | Connex Cardio PC based 12-Lead Multi-Channel Resting ECG - software, Connex Card Connex Cardio PC based 12-Lead Multi-Channel Resting ECG - software, Connex Cardio WAM wireless acquisition module, AHA 10 wire, 12-lead lead set with banana plugs, CardioSens Ultra II resting tab electrodes (pouch of 100), Clear Choice adapter clips (set of 10), Connex Cardio UTK | Welch Allyn, Inc. | WELCH ALLYN, INC. |
33 | 00817655022598 | 901128 | CC-RXX-WADX | Connex Cardio PC based 12-Lead Multi-Channel Resting ECG - software, Connex Card Connex Cardio PC based 12-Lead Multi-Channel Resting ECG - software, Connex Cardio WAM wireless acquisition module, AHA 10 wire, 12-lead lead set with banana plugs, CardioSens Ultra II resting tab electrodes (pouch of 100), Clear Choice adapter clips (set of 10), Connex Cardio UTK, DICOM | Welch Allyn, Inc. | WELCH ALLYN, INC. |
34 | 00817655022581 | ELI280-AAA-AAFAT | Electrocardiograph | ELI 280 | MORTARA INSTRUMENT, INC. | |
35 | 00817655022574 | ELI250c-CAC-ADCAX | Electrocardiograph | ELI 250c | MORTARA INSTRUMENT, INC. | |
36 | 00817655022543 | XSCRIBE-6AC-AAAXX | Cardiac Stress Testing System | XScribe | MORTARA INSTRUMENT, INC. | |
37 | 00817655022536 | XSCRIBE-6AC-AAAAX | Cardiac Stress Testing System | XScribe | MORTARA INSTRUMENT, INC. | |
38 | 00817655022475 | MDLTYMGR-5BC-XXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
39 | 00817655022468 | MDLTYMGR-5BC-DXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
40 | 00817655022451 | MDLTYMGR-5AE-AXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
41 | 00817655022444 | MDLTYMGR-5AD-AXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
42 | 00817655022437 | MDLTYMGR-5AC-XXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
43 | 00817655022420 | MDLTYMGR-5AC-XXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
44 | 00817655022413 | MDLTYMGR-5AC-XXXXA | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
45 | 00817655022406 | MDLTYMGR-5AC-DXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
46 | 00817655022390 | MDLTYMGR-5AC-DXXXB | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
47 | 00817655022383 | MDLTYMGR-5AC-DXXXA | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
48 | 00817655022376 | MDLTYMGR-5AC-CXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
49 | 00817655022369 | MDLTYMGR-5AC-CXXXA | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. | |
50 | 00817655022352 | MDLTYMGR-5AC-BXXXX | Cardiology Information System Workstation | Modality Manager | MORTARA INSTRUMENT, INC. |