| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 08031527014487 | 2.42UG1 | NVZ | Pulse generator, permanent, implantable | 3 | Smartview | ||
| 2 | 08031527013909 | 4,5m | NVZ | Pulse generator, permanent, implantable | 3 | ECG Cable | ||
| 3 | 08031527013435 | V3.10 | DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | 2 | SYNECOM | ||
| 4 | 08031527013411 | SD card | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | SPIDERVIEW SD MEMORY CARD | ||
| 5 | 08031527016023 | 7 leads | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | SPIDERVIEW | ||
| 6 | 08031527014210 | None | NVZ | Pulse generator, permanent, implantable | 3 | ORCHESTRA PLUS LINK | ||
| 7 | 08031527015132 | SPIDERVIEW | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | CUSTODIA | ||
| 8 | 08031527012247 | SR | NVZ | Pulse generator, permanent, implantable | 3 | Reply | ||
| 9 | 08031527011523 | DR | NVZ | Pulse generator, permanent, implantable | 3 | Reply | ||
| 10 | 08031527017877 | KC961 | KC961 | MicroPort SmartView monitor V2+ | OSR | Pacemaker/Icd/Crt Non-Implanted Components | 3 | SmartView monitor |
| 11 | 08031527014296 | V3.10 USB COM | DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | 2 | EASYSCOPE | ||
| 12 | 08031527015149 | Pouch | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | SPIDERVIEW | ||
| 13 | 08031527015095 | 3 Leads XYZ / 7E | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | SPIDERVIEW | ||
| 14 | 08031527015088 | 2 Leads / 5 E | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | SPIDERVIEW | ||
| 15 | 08031527015071 | 12 Leads / 10 E | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | SPIDERVIEW | ||
| 16 | 08031527015064 | XYZ-HR / 7E | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | SPIDERVIEW | ||
| 17 | 08031527013398 | SPIDERVIEW | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | SPIDERVIEW | ||
| 18 | 08031527009629 | Reply/Esprit | NVZ | Pulse generator, permanent, implantable | 3 | Screwdriver | ||
| 19 | 08031527009230 | ICD | MRM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | 3 | Screwdriver | ||
| 20 | 08031527009162 | SR | NVZ | Pulse generator, permanent, implantable | 3 | Esprit | ||
| 21 | 08031527009056 | DR | NVZ | Pulse generator, permanent, implantable | 3 | Esprit | ||
| 22 | 08031527014944 | V3.10 UPG TO USB COM | DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | 2 | EASYSCOPE | ||
| 23 | 08031527014890 | PLUS | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | SPIDERVIEW | ||
| 24 | 08031527014876 | SPIDERVIEW | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | SPIDERVIEW | ||
| 25 | 08031527012810 | CRT-D 174 | NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) | 3 | Intensia | ||
| 26 | 08031527013893 | 3.3 | MRM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | 3 | Remote Monitoring System | ||
| 27 | 08031527012834 | VR 124 | MRM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | 3 | Intensia | ||
| 28 | 08031527012827 | DR 154 | MRM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | 3 | Intensia | ||
| 29 | 08031527017020 | G999 | G999 | MicroPort CRM USB adapter for CPR3H | OSR | Pacemaker/Icd/Crt Non-Implanted Components | 3 | USB adapter for CPR3H |
| 30 | 08031527014883 | SD Card | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | SPIDERVIEW+ SD MEMORY CARD | ||
| 31 | 08031527014654 | 3.4 | MRM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | 3 | Remote Monitoring System | ||
| 32 | 08031527014289 | SYNESCOPE V3.10 USB | DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | 2 | SYNESCOPE | ||
| 33 | 08031527015057 | 2 Leads / 3E | MWJ | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | 2 | SPIDERVIEW / SPIDERFLASH | ||
| 34 | 08031527013350 | CPR3 | NVZ | Pulse generator, permanent, implantable | 3 | CPR3 | ||
| 35 | 08031527018089 | KC861 | KC861 | MicroPort Smart Spot (IMV2+) / CPR4BR adapter | OSR | Pacemaker/Icd/Crt Non-Implanted Components | 3 | Smart Spot with CPR4BR accessory |
| 36 | 08031527015040 | UPGRADE TO SYNESCOPE V3.10 USB | DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | 2 | SYNESCOPE | ||
| 37 | 08031527015033 | NETWORK LICENCE V3,10 USB | DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | 2 | SYNESCOPE | ||
| 38 | 08031527013916 | 3m | NVZ | Pulse generator, permanent, implantable | 3 | ECG Cable | ||
| 39 | 08031527019956 | TAC004C | TAC004C | MicroPort CRM Magnet | DTG | Magnet, Test, Pacemaker | 1 | Magnet |
| 40 | 08031527013381 | Wireless | MRM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | 3 | Smartview Monitor | ||
| 41 | 08031527013374 | Landline | MRM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | 3 | Smartview Monitor | ||
| 42 | 08031527012278 | CRT-D 9750 | NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) | 3 | Paradym RF | ||
| 43 | 08031527012261 | VR 9250 | MRM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | 3 | Paradym RF | ||
| 44 | 08031527012254 | DR 9550 | MRM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | 3 | Paradym RF | ||
| 45 | 08031527017013 | GB78 | GB78 | MicroPort CRM CPR3H telemetry head for SmartTouch | OSR | Pacemaker/Icd/Crt Non-Implanted Components | 3 | CPR3H |
| 46 | 08031527015569 | 4LV CRT-D 1744 | NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) | 3 | PLATINIUM | ||
| 47 | 08031527015538 | CRT-D 1711 | NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) | 3 | PLATINIUM | ||
| 48 | 08031527015460 | VR 1240 | MRM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | 3 | PLATINIUM | ||
| 49 | 08031527017754 | B10000 | B10000 | MicroPort CPR4BR accessory | OSR | Pacemaker/Icd/Crt Non-Implanted Components | 3 | CPR4BR accessory |
| 50 | 08031527017334 | K379 | K379 | MicroPort CRM Smart ECG | MRM | Defibrillator, Implantable, Dual-Chamber | 3 | Smart ECG |
| 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 |