No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10846835009439 | D129707 | D129707 | DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | 2 | Carto 3 | |
2 | 10846835000573 | NI75TCJH | NI75TCJH | OAD | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | 3 | NaviStar ThermoCool | |
3 | 10846835002379 | ADSTK | ADSTK | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | N/A | |
4 | 10846835022056 | D134402 | D134402 | Interface Cable | MTD | Catheter, intracardiac mapping, high-density array | 2 | CARTO 3 System eco Interface Cable |
5 | 10846835012620 | D135305 | D135305 | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | WEBSTER CS | |
6 | 10846835010046 | D134909 | D134909 | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | Lasso Nav | |
7 | 10846835009989 | D135304 | D135304 | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | WEBSTER CS | |
8 | 10846835009972 | D135303 | D135303 | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | WEBSTER CS | |
9 | 10846835009651 | D134901 | D134901 | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | Lasso Nav | |
10 | 10846835008913 | D128709 | D128709 | DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | 2 | N/A | |
11 | 10846835008890 | D128623 | D128623 | DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | 2 | N/A | |
12 | 10846835008647 | OF63X4C010FS | OF63X4C010FS | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | N/A | |
13 | 10846835008357 | NI75TCCH | NI75TCCH | OAD | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | 3 | NaviStar ThermoCool | |
14 | 10846835008333 | NI75TCBH | NI75TCBH | OAD | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | 3 | NaviStar ThermoCool | |
15 | 10846835008296 | LN222515CT | LN222515CT | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | Lasso | |
16 | 10846835008272 | LN122515CT | LN122515CT | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | Lasso | |
17 | 10846835006827 | DLN2220CT | DLN2220CT | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | Lasso Nav | |
18 | 10846835006797 | DLN1220CT | DLN1220CT | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | Lasso Nav | |
19 | 10846835006353 | D8BRFL252RT | D8BRFL252RT | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | N/A | |
20 | 10846835006322 | D8BRDL252RT | D8BRDL252RT | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | N/A | |
21 | 10846835006292 | D8BRCG252RT | D8BRCG252RT | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | N/A | |
22 | 10846835005912 | D7PSL252RT | D7PSL252RT | LPB | Cardiac ablation percutaneous catheter | 3 | N/A | |
23 | 10846835005882 | D7L2030RT | D7L2030RT | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | Lasso | |
24 | 10846835005875 | D7L2025RT | D7L2025RT | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | Lasso | |
25 | 10846835005868 | D7L2020CT | D7L2020CT | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | Lasso | |
26 | 10846835005851 | D7L2015CT | D7L2015CT | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | Lasso | |
27 | 10846835005820 | D7L1025RT | D7L1025RT | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | Lasso | |
28 | 10846835005813 | D7L1020CT | D7L1020CT | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | Lasso | |
29 | 10846835005806 | D7L1015CT | D7L1015CT | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | Lasso | |
30 | 10846835005790 | D7L1012RT | D7L1012RT | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | Lasso | |
31 | 10846835005714 | D7FL252RT | D7FL252RT | LPB | Cardiac ablation percutaneous catheter | 3 | N/A | |
32 | 10846835005684 | D7EL252RT | D7EL252RT | LPB | Cardiac ablation percutaneous catheter | 3 | N/A | |
33 | 10846835005660 | D7EG252RT | D7EG252RT | LPB | Cardiac ablation percutaneous catheter | 3 | N/A | |
34 | 10846835005608 | D7DL252RT | D7DL252RT | LPB | Cardiac ablation percutaneous catheter | 3 | N/A | |
35 | 10846835005592 | D7DL252PS | D7DL252PS | LPB | Cardiac ablation percutaneous catheter | 3 | N/A | |
36 | 10846835005554 | D7CL252RT | D7CL252RT | LPB | Cardiac ablation percutaneous catheter | 3 | N/A | |
37 | 10846835005530 | D7CG252RT | D7CG252RT | LPB | Cardiac ablation percutaneous catheter | 3 | N/A | |
38 | 10846835005110 | D7BL252RT | D7BL252RT | LPB | Cardiac ablation percutaneous catheter | 3 | N/A | |
39 | 10846835005080 | D7AL252RT | D7AL252RT | LPB | Cardiac ablation percutaneous catheter | 3 | N/A | |
40 | 10846835005073 | D7AL252PS | D7AL252PS | LPB | Cardiac ablation percutaneous catheter | 3 | N/A | |
41 | 10846835005042 | D7A20131RT | D7A20131RT | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | CRISTA CATH | |
42 | 10846835004861 | D708RHISRT | D708RHISRT | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | PARAHISIAN | |
43 | 10846835003697 | C6MR10MLTCS | C6MR10MLTCS | OAD | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | 3 | N/A | |
44 | 10846835003680 | C6MR10EPTST | C6MR10EPTST | OAD | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | 3 | N/A | |
45 | 10846835003666 | C6MR10EPTRS | C6MR10EPTRS | OAD | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | 3 | N/A | |
46 | 10846835003628 | C6FST6MST6 | C6FST6MST6 | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | N/A | |
47 | 10846835003420 | C3FFMST12X | C3FFMST12X | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | N/A | |
48 | 10846835003413 | C3FFMST10X | C3FFMST10X | DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 2 | N/A | |
49 | 10846835003406 | C10MRMSTKDTCS | C10MRMSTKDTCS | OAD | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | 3 | N/A | |
50 | 10846835003055 | BN7TCJJ4L | BN7TCJJ4L | LPB | Cardiac ablation percutaneous catheter | 3 | EZ Steer NAV |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 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 |
2 | 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 | |
3 | B546VENDYS1 | JK-001V | VENDYS II | ENDOTHELIX, INC. | ||
4 | B320VH120 | VH12 | Premier Heart MCG 12 Lead capture hardware. | Premier Heart MCG Model VH12 | PREMIER HEART, LLC | |
5 | 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 | |
6 | B320CF190 | CF19 | CF19 | Premier Heart MCG Model CF19 | Premier Heart MCG | PREMIER HEART, LLC |
7 | B273CEA0 | 2.1.xx | Cardiologs ECG analysis platform | Cardiologs Platform | CARDIOLOGS TECHNOLOGIES | |
8 | 80010939050027 | 14.0 | McKesson Cardiology Hemo | MCKESSON TECHNOLOGIES INC. | ||
9 | 80010939050010 | 13.2.1 | McKesson Cardiology Hemo | MCKESSON TECHNOLOGIES INC. | ||
10 | 80010939040028 | 14.0 | McKesson Cardiology ECG Management | MCKESSON TECHNOLOGIES INC. | ||
11 | 80010939040011 | 13.2.1 | McKesson Cardiology ECG Management | MCKESSON TECHNOLOGIES INC. | ||
12 | 20857553006072 | M300-5 | M300-5 | Stealth System Wearable Sensor (M300). | Stealth System S300 | CARDIAC INSIGHT, INC. |
13 | 17540262120028 | 1.3 | Change Healthcare Cardiology ECG Mobile | CHANGE HEALTHCARE ISRAEL LTD | ||
14 | 17540262120011 | 1.2.4 | Change Healthcare Cardiology ECG Mobile | CHANGE HEALTHCARE ISRAEL LTD | ||
15 | 17540262110104 | 15.0.1 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE CANADA COMPANY | ||
16 | 17540262110098 | 15.0 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE CANADA COMPANY | ||
17 | 17540262110050 | 14.3.2 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE CANADA COMPANY | ||
18 | 17540262110043 | 14.3 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE CANADA COMPANY | ||
19 | 17540262110036 | 14.2 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE CANADA COMPANY | ||
20 | 17540262110029 | 14.1.1 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE ISRAEL LTD | ||
21 | 17540262110012 | 14.1 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE ISRAEL LTD | ||
22 | 17540262100105 | 15.0.1 | Change Healthcare Cardiology Hemo | CHANGE HEALTHCARE CANADA COMPANY | ||
23 | 17540262100099 | 15.0 | Change Healthcare Cardiology Hemo | CHANGE HEALTHCARE CANADA COMPANY | ||
24 | 17540262100051 | 14.3.2 | Change Healthcare Cardiology Hemo | CHANGE HEALTHCARE CANADA COMPANY | ||
25 | 17540262100044 | 14.3 | Change Healthcare Cardiology Hemo | CHANGE HEALTHCARE CANADA COMPANY | ||
26 | 17540262100037 | 14.2 | Change Healthcare Cardiology Hemo | CHANGE HEALTHCARE CANADA COMPANY | ||
27 | 17540262100020 | 14.1.1 | Change Healthcare Cardiology Hemo | CHANGE HEALTHCARE ISRAEL LTD | ||
28 | 17540262100013 | 14.1 | Change Healthcare Cardiology Hemo | CHANGE HEALTHCARE ISRAEL LTD | ||
29 | 15415067025934 | EN0020-P | EN0020-P | Surface Electrode Kit | EnSite Precision™ | ST. JUDE MEDICAL, INC. |
30 | 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. |
31 | 10857553006112 | M300-5 | M300-5 | Cardea SOLO Wearable Sensor (M300) | Cardea SOLO | CARDIAC INSIGHT, INC. |
32 | 10846835012576 | D128624 | D128624 | Carto 3 | BIOSENSE WEBSTER INC | |
33 | 10846835011678 | FG170000 | FG170000 | NOGA XP-Cardiac Mapping System | NOGA XP | BIOSENSE WEBSTER (ISRAEL) LTD. |
34 | 10846835009439 | D129707 | D129707 | Carto 3 | BIOSENSE WEBSTER INC | |
35 | 10846835009422 | D129704 | D129704 | Carto 3 | BIOSENSE WEBSTER INC | |
36 | 10846835008913 | D128709 | D128709 | N/A | BIOSENSE WEBSTER INC | |
37 | 10846835008906 | D128627 | D128627 | CARTO 3 | BIOSENSE WEBSTER INC | |
38 | 10846835008890 | D128623 | D128623 | N/A | BIOSENSE WEBSTER INC | |
39 | 10846835008883 | D128622 | D128622 | CARTO 3 | BIOSENSE WEBSTER INC | |
40 | 10846835003925 | CY1212CT | CY1212CT | Carto 3 | BIOSENSE WEBSTER INC | |
41 | 10846835003918 | CY1210CT | CY1210CT | Carto 3 | BIOSENSE WEBSTER INC | |
42 | 10846835003871 | CR3434CT | CR3434CT | Carto 3 | BIOSENSE WEBSTER INC | |
43 | 10846835003857 | CR3425CT | CR3425CT | Carto 3 | BIOSENSE WEBSTER INC | |
44 | 10846835003826 | CG2025CT | CG2025CT | Carto 3 | BIOSENSE WEBSTER INC | |
45 | 10846835003802 | CB3434CT | CB3434CT | Carto 3 | BIOSENSE WEBSTER INC | |
46 | 10846835003796 | CB3412CT | CB3412CT | Carto 3 | BIOSENSE WEBSTER INC | |
47 | 10846835003789 | CB3410CT | CB3410CT | Carto 3 | BIOSENSE WEBSTER INC | |
48 | 10846835000870 | FG540000 | FG-5400-00 | CARTO 3 | CARTO 3 | BIOSENSE WEBSTER (ISRAEL) LTD. |
49 | 10841522129551 | 98201 | 040-1766-00 | UPGRADE, SENTINEL 10.5 TO 11.5 OR HIGHER | Sentinel | SPACELABS HEALTHCARE (WASHINGTON), INC |
50 | 10841522129537 | 98000 | 98000SL | PATHFINDER SL ANALYSER | PATHFINDER | SPACELABS HEALTHCARE (WASHINGTON), INC |