No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 05415067024084 | 1192 | 1192 | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | Swift-Lock™ | |
2 | 05414734406123 | 3183 | 3183 | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | Octrode™ | |
3 | 05414734202459 | 401780 | 401780 | DRF,DRA | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING,CATHETER, STEERABLE | 2 | Livewire™ | |
4 | 05414734203319 | 406805 | 406805 | DYB | INTRODUCER, CATHETER | 2 | Fast-Cath™ | |
5 | 05414734022491 | 406311 | 406311 | DYB | INTRODUCER, CATHETER | 2 | SJM™ | |
6 | 05414734011730 | 406743 | 406743 | DYB | INTRODUCER, CATHETER | 2 | Fast-Cath™ | |
7 | 05414734010832 | 406667 | 406667 | DYB | INTRODUCER, CATHETER | 2 | Maximum™ | |
8 | 05414734206938 | PL | 410187 | DQY | CATHETER, PERCUTANEOUS | 2 | CPS DIRECT™ | |
9 | 05415067017246 | 3186 | 3186 | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | Octrode™ | |
10 | 05415067011107 | A701124 | A701124 | OAD | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | 3 | FlexAbility™ | |
11 | 05415067025722 | X | C12359 | Guidewire | DXO,DRG,DQX | TRANSDUCER, PRESSURE, CATHETER TIP,TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIG TRANSDUCER, PRESSURE, CATHETER TIP,TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY,WIRE, GUIDE, CATHETER | PressureWire™ | |
12 | 05415067019615 | 3688 | 3688 | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | Eon C™ | |
13 | 05415067016560 | 3032 | 3032 | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | SJM™ | |
14 | 05414734506779 | DS06003/40 | DS06003/40 | DRB | STYLET, CATHETER | 2 | SJM™ | |
15 | 05414734506762 | DS06002/85 | DS06002/85 | DRB | STYLET, CATHETER | 2 | SJM™ | |
16 | 05414734505345 | DS2M028 | DS2M028 | Guidewire | DQX | WIRE, GUIDE, CATHETER | 2 | CPS Excel™ |
17 | 05414734503662 | DS06003/52 | DS06003/52 | DRB | STYLET, CATHETER | 2 | SJM™ | |
18 | 05415067018052 | H701805 | H701805 | Printer | DQK | Computer, diagnostic, programmable | 2 | NA |
19 | 05414734206914 | PL | 410185 | DQY | CATHETER, PERCUTANEOUS | 2 | CPS DIRECT™ | |
20 | 05414734406130 | 3186 | 3186 | Lead Kit, 60cm Length | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | Octrode™ |
21 | 05414734406024 | 3086 | 3086 | GZB | STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) | 2 | Octrode™ | |
22 | 05414734405775 | 3852 | 3852 | Patient Programmer | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
23 | 05414734405133 | 1622 | 1622 | Power Adapter, RP Model 3834 | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
24 | 05414734403382 | 7241 | 7241 | Mobile Charger Pouch | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
25 | 05414734402569 | 3714 | 3714 | AC Line Cord | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
26 | 05414734402552 | 3713 | 3713 | AC Power Adapter | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
27 | 05414734402330 | 3386 | 3386 | Extension, 60cm | GZB | STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) | 2 | NA |
28 | 05414734402323 | 3383 | 3383 | Extension, 30cm | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
29 | 05414734402309 | 3346 | 3346 | Extension, Dual 4 Channel 60cm | GZB | STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) | 2 | NA |
30 | 05414734402293 | 3343 | 3343 | Extension, Dual 4 Channel 30cm | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
31 | 05414734402279 | 3341 | 3341 | Extension, Dual 4 Channel 10cm | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
32 | 05414734400206 | 1123 | 1123 | Stylet, Straight, 60cm | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
33 | 05414734401715 | 3189 | 3189 | Lead Kit, 90cm Length | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | Octrode™ |
34 | 05414734401555 | 3086 | 3086 | Trial Lead Kit, 60cm Length | GZB | STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) | 2 | Octrode™ |
35 | 05414734401173 | 1701 | 1701 | SCS Accessory Kit Sterile | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
36 | 05414734400664 | 1191 | 1191 | Tunneling Tool, 0.156"¿ Diameter | HAO | INSTRUMENT, SURGICAL, NON-POWERED | 1 | NA |
37 | 05414734400657 | 1190 | 1190 | Tunneling Tool, 0.125" Diameter | HAO | INSTRUMENT, SURGICAL, NON-POWERED | 1 | NA |
38 | 05414734400237 | 1126 | 1126 | Stylet, Curved, 90cm | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
39 | 05414734400220 | 1125 | 1125 | Stylet, Straight, 90cm | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | NA | |
40 | 05414734400213 | 1124 | 1124 | Stylet, Bent, 60cm | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
41 | 05414734400190 | 1122 | 1122 | Stylet, Bent, 30cm | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
42 | 05414734400183 | 1121 | 1121 | Stylet, Straight, 30cm | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
43 | 05414734400145 | 1116 | 1116 | Epidural Needle, 14 gauge, 6" (15cm) | LHG,GZB | ELECTRODE, SPINAL EPIDURAL,STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) | 2 | NA |
44 | 05414734400121 | 1114 | 1114 | Epidural Needle, 14 gauge, 4" (10cm) | GZB | STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) | 2 | NA |
45 | 05414734400053 | 1106 | 1106 | Lead Anchor, Long | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
46 | 05414734400022 | 1102 | 1102 | Guide Wire for Percutaneous Leads | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA |
47 | 05414734219112 | H21911 | H21911 | Touch Screen Computer | JOQ | GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE | 2 | EP-4™ |
48 | 05414734206907 | PL | 410184 | DQY | CATHETER, PERCUTANEOUS | 2 | CPS DIRECT™ | |
49 | 05414734218337 | DS2A004 | DS2A004 | DQY | CATHETER, PERCUTANEOUS | 2 | CPS DIRECT™ | |
50 | 05414734218313 | SLII | DS2C017 | Slittable Outer Guide Catheter | DQY | CATHETER, PERCUTANEOUS | 2 | CPS DIRECT™ |
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 |