No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00817655022574 | ELI250c-CAC-ADCAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
2 | 00817655022475 | MDLTYMGR-5BC-XXXXX | Cardiology Information System Workstation | DPS,MLO | Electrocardiograph,Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | Modality Manager | |
3 | 00817655022468 | MDLTYMGR-5BC-DXXXB | Cardiology Information System Workstation | MLO,DPS | Electrocardiograph, Ambulatory, With Analysis Algorithm,Electrocardiograph | 2 | Modality Manager | |
4 | 00817655022451 | MDLTYMGR-5AE-AXXXB | Cardiology Information System Workstation | DPS,MLO | Electrocardiograph,Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | Modality Manager | |
5 | 00817655022444 | MDLTYMGR-5AD-AXXXB | Cardiology Information System Workstation | MLO,DPS | Electrocardiograph, Ambulatory, With Analysis Algorithm,Electrocardiograph | 2 | Modality Manager | |
6 | 00817655022437 | MDLTYMGR-5AC-XXXXX | Cardiology Information System Workstation | DPS,MLO | Electrocardiograph,Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | Modality Manager | |
7 | 00817655022420 | MDLTYMGR-5AC-XXXXB | Cardiology Information System Workstation | MLO,DPS | Electrocardiograph, Ambulatory, With Analysis Algorithm,Electrocardiograph | 2 | Modality Manager | |
8 | 00817655022413 | MDLTYMGR-5AC-XXXXA | Cardiology Information System Workstation | DPS,MLO | Electrocardiograph,Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | Modality Manager | |
9 | 00817655022406 | MDLTYMGR-5AC-DXXXX | Cardiology Information System Workstation | MLO,DPS | Electrocardiograph, Ambulatory, With Analysis Algorithm,Electrocardiograph | 2 | Modality Manager | |
10 | 00817655022390 | MDLTYMGR-5AC-DXXXB | Cardiology Information System Workstation | DPS,MLO | Electrocardiograph,Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | Modality Manager | |
11 | 00817655022383 | MDLTYMGR-5AC-DXXXA | Cardiology Information System Workstation | MLO,DPS | Electrocardiograph, Ambulatory, With Analysis Algorithm,Electrocardiograph | 2 | Modality Manager | |
12 | 00817655022376 | MDLTYMGR-5AC-CXXXX | Cardiology Information System Workstation | DPS,MLO | Electrocardiograph,Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | Modality Manager | |
13 | 00817655022352 | MDLTYMGR-5AC-BXXXX | Cardiology Information System Workstation | DPS,MLO | Electrocardiograph,Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | Modality Manager | |
14 | 00817655022345 | MDLTYMGR-5AC-BXXXB | Cardiology Information System Workstation | MLO,DPS | Electrocardiograph, Ambulatory, With Analysis Algorithm,Electrocardiograph | 2 | Modality Manager | |
15 | 00817655022338 | MDLTYMGR-5AC-BXXXA | Cardiology Information System Workstation | DPS,MLO | Electrocardiograph,Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | Modality Manager | |
16 | 00817655022321 | MDLTYMGR-5AC-AXXXX | Cardiology Information System Workstation | MLO,DPS | Electrocardiograph, Ambulatory, With Analysis Algorithm,Electrocardiograph | 2 | Modality Manager | |
17 | 00817655022314 | MDLTYMGR-5AC-AXXXB | Cardiology Information System Workstation | DPS,MLO | Electrocardiograph,Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | Modality Manager | |
18 | 00817655022307 | MDLTYMGR-5AC-AXXXA | Cardiology Information System Workstation | MLO,DPS | Electrocardiograph, Ambulatory, With Analysis Algorithm,Electrocardiograph | 2 | Modality Manager | |
19 | 00817655022291 | MDLTYMGR-5AA-AXXXB | Cardiology Information System Workstation | DPS,MLO | Electrocardiograph,Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | Modality Manager | |
20 | 00817655022253 | MDLTYMGR-5AA-AXXXA | Cardiology Information System Workstation | MLO,DPS | Electrocardiograph, Ambulatory, With Analysis Algorithm,Electrocardiograph | 2 | Modality Manager | |
21 | 00817655022123 | ELI150c-BEA-ACGBD | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
22 | 00817655020358 | ELI250c-BAA-ADAAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
23 | 00817655020341 | ELI150c-BAA-ADAAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
24 | 00817655020327 | ELI150c-IAB-AFHAB | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
25 | 00817655021973 | ELI250c-AAC-AAAAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
26 | 00817655021935 | QS-6ID-AGDAA | Cardiac Stress Testing System | DPS | Electrocardiograph | 2 | Q-Stress | |
27 | 00817655021881 | QS-6FC-AXDXA | Cardiac Stress Testing System | DPS | Electrocardiograph | 2 | Q-Stress | |
28 | 00817655021867 | ELI150c-AAA-AACAD | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
29 | 00817655021843 | ELI150c-DAA-AAHAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
30 | 00817655021805 | ELI150c-HAA-ADGBD | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
31 | 00817655021799 | ELI250c-CAA-ADFBD | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
32 | 00817655021768 | ELI150c-CAA-AAHAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
33 | 00817655021751 | ELI150c-GAA-ABCBX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
34 | 00817655021645 | ELI250c-EAA-AAAAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
35 | 00817655021478 | ELI250c-MAA-ABBAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
36 | 00817655021423 | 41000-030-64 | Cardiopulmonary accessory kit cleared with XScribe | DPS | Electrocardiograph | 2 | XScribe Cardiopulmonary Kit | |
37 | 00817655021416 | ELI250c-CAA-ADAAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
38 | 00817655021409 | ELI250c-AAA-ADAAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
39 | 00817655021393 | ELI150c-CAA-AFHAB | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
40 | 00817655021386 | ELI250c-KAA-ADFAD | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
41 | 00817655021355 | QS-6AA-DDCAA | Cardiac Stress Testing System | DPS | Electrocardiograph | 2 | Q-Stress | |
42 | 00817655021331 | QS-6GD-XGDAA | Cardiac Stress Testing System | DPS | Electrocardiograph | 2 | Q-Stress | |
43 | 00817655021324 | ELI250c-MAA-AABAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
44 | 00817655021317 | ELI150c-BAA-AACAD | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
45 | 00817655021300 | ELI250c-CAA-AACAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
46 | 00817655021119 | QS-6HD-AXAAA | Cardiac Stress Testing System | DPS | Electrocardiograph | 2 | Q-Stress | |
47 | 00817655023014 | ELI250c-CAA-AACBX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c | |
48 | 00817655023007 | ELI150c-AAA-ABAAX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
49 | 00817655022994 | ELI150c-GEA-ABCBX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 150c | |
50 | 00817655022963 | ELI250c-MAA-ABCBX | Electrocardiograph | DPS | Electrocardiograph | 2 | ELI 250c |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00195278516015 | AltiX | 5896597 | Upgrade Kit MLCL V8.0 | MLCL Upgrade | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
2 | 00195278507525 | AltiX | 5889605 | Software Medical Device GE Client Software V8.0 | MLCL Client Software | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
3 | 00195278507051 | AltiX | 2300000-005 | Computer ComboLab Acquisition v8.0 | ComboLab | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
4 | 00195278507044 | AltiX | 2300000-004 | Computer CardioLab Acquisition v8.0 | CardioLab | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
5 | 00195278288639 | MBZ323 | 2087075-300 | CARESCAPE ONE MBZ323 ATO MODEL | CARESCAPE ONE | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
6 | 00191506017224 | H749009881CD0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
7 | 00191506017187 | H749009765R0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
8 | 00191506015206 | H749009881IZ0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
9 | 00191506015190 | H749009881IR0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
10 | 00191506015183 | H749009881I0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
11 | 00191506015176 | H749009881CZ0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
12 | 00191506015169 | H749009881CR0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
13 | 00191506015152 | H749009881C0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
14 | 00191506015084 | H7490097650 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
15 | 00191506000813 | M004RAPATCH20 | M004RAPATCH20 | Location Reference Patch Kit | Rhythmia HDx™ Mapping System | BOSTON SCIENTIFIC CORPORATION |
16 | B972CCZ12050482050 | 4 | CCZ1205048205 | CER-S is stand-alone software medical device, providing advanced solutions for i CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data. | CER-S | CARDIO CALM SRL |
17 | B972CCZ12050482030 | 4 | CER-S is stand-alone software medical device, providing advanced solutions for i CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data. | CER-S | CARDIO CALM SRL | |
18 | B546VENDYS1 | JK-001V | VENDYS II | ENDOTHELIX, INC. | ||
19 | B320VH120 | VH12 | Premier Heart MCG 12 Lead capture hardware. | Premier Heart MCG Model VH12 | PREMIER HEART, LLC | |
20 | B320MCGC0 | MCGC | Premier Heart MCG Analysis Cluster software, including: - MCG Clinical Client ( Premier Heart MCG Analysis Cluster software, including: - MCG Clinical Client (reference implementation and API) - MCG Webapps/Report Generator - MCG Clinical Database - MCG Analysis Engine | Premier Heart MCG Analysis Software | PREMIER HEART, LLC | |
21 | B320CF190 | CF19 | CF19 | Premier Heart MCG Model CF19 | Premier Heart MCG | PREMIER HEART, LLC |
22 | B273CEA0 | 2.1.xx | Cardiologs ECG analysis platform | Cardiologs Platform | CARDIOLOGS TECHNOLOGIES | |
23 | 80010939050027 | 14.0 | McKesson Cardiology Hemo | MCKESSON TECHNOLOGIES INC. | ||
24 | 80010939050010 | 13.2.1 | McKesson Cardiology Hemo | MCKESSON TECHNOLOGIES INC. | ||
25 | 80010939040028 | 14.0 | McKesson Cardiology ECG Management | MCKESSON TECHNOLOGIES INC. | ||
26 | 80010939040011 | 13.2.1 | McKesson Cardiology ECG Management | MCKESSON TECHNOLOGIES INC. | ||
27 | 20857553006072 | M300-5 | M300-5 | Stealth System Wearable Sensor (M300). | Stealth System S300 | CARDIAC INSIGHT, INC. |
28 | 17540262120028 | 1.3 | Change Healthcare Cardiology ECG Mobile | CHANGE HEALTHCARE ISRAEL LTD | ||
29 | 17540262120011 | 1.2.4 | Change Healthcare Cardiology ECG Mobile | CHANGE HEALTHCARE ISRAEL LTD | ||
30 | 17540262110104 | 15.0.1 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE CANADA COMPANY | ||
31 | 17540262110098 | 15.0 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE CANADA COMPANY | ||
32 | 17540262110050 | 14.3.2 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE CANADA COMPANY | ||
33 | 17540262110043 | 14.3 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE CANADA COMPANY | ||
34 | 17540262110036 | 14.2 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE CANADA COMPANY | ||
35 | 17540262110029 | 14.1.1 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE ISRAEL LTD | ||
36 | 17540262110012 | 14.1 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE ISRAEL LTD | ||
37 | 17540262100105 | 15.0.1 | Change Healthcare Cardiology Hemo | CHANGE HEALTHCARE CANADA COMPANY | ||
38 | 17540262100099 | 15.0 | Change Healthcare Cardiology Hemo | CHANGE HEALTHCARE CANADA COMPANY | ||
39 | 17540262100051 | 14.3.2 | Change Healthcare Cardiology Hemo | CHANGE HEALTHCARE CANADA COMPANY | ||
40 | 17540262100044 | 14.3 | Change Healthcare Cardiology Hemo | CHANGE HEALTHCARE CANADA COMPANY | ||
41 | 17540262100037 | 14.2 | Change Healthcare Cardiology Hemo | CHANGE HEALTHCARE CANADA COMPANY | ||
42 | 17540262100020 | 14.1.1 | Change Healthcare Cardiology Hemo | CHANGE HEALTHCARE ISRAEL LTD | ||
43 | 17540262100013 | 14.1 | Change Healthcare Cardiology Hemo | CHANGE HEALTHCARE ISRAEL LTD | ||
44 | 15415067025934 | EN0020-P | EN0020-P | Surface Electrode Kit | EnSite Precision™ | ST. JUDE MEDICAL, INC. |
45 | 10857553006129 | C300/D300 | C300/D300 | Cardea SOLO Analysis Package - ECG analysis software (D300) and data transfer ca Cardea SOLO Analysis Package - ECG analysis software (D300) and data transfer cable (C300). | Cardea SOLO | CARDIAC INSIGHT, INC. |
46 | 10857553006112 | M300-5 | M300-5 | Cardea SOLO Wearable Sensor (M300) | Cardea SOLO | CARDIAC INSIGHT, INC. |
47 | 10846835012576 | D128624 | D128624 | Carto 3 | BIOSENSE WEBSTER INC | |
48 | 10846835011678 | FG170000 | FG170000 | NOGA XP-Cardiac Mapping System | NOGA XP | BIOSENSE WEBSTER (ISRAEL) LTD. |
49 | 10846835009439 | D129707 | D129707 | Carto 3 | BIOSENSE WEBSTER INC | |
50 | 10846835009422 | D129704 | D129704 | Carto 3 | BIOSENSE WEBSTER INC |