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 | 00191506017224 | H749009881CD0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
2 | 00191506017224 | H749009881CD0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
3 | 00191506017187 | H749009765R0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
4 | 00191506017187 | H749009765R0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
5 | 00191506015206 | H749009881IZ0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
6 | 00191506015206 | H749009881IZ0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
7 | 00191506015190 | H749009881IR0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
8 | 00191506015190 | H749009881IR0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
9 | 00191506015183 | H749009881I0 | 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 | 00191506015176 | H749009881CZ0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
13 | 00191506015169 | H749009881CR0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
14 | 00191506015169 | H749009881CR0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
15 | 00191506015152 | H749009881C0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
16 | 00191506015152 | H749009881C0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
17 | 00191506015084 | H7490097650 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
18 | 00191506015084 | H7490097650 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
19 | 00191506000813 | M004RAPATCH20 | M004RAPATCH20 | Location Reference Patch Kit | Rhythmia HDx™ Mapping System | BOSTON SCIENTIFIC CORPORATION |
20 | 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 |
21 | 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 | |
22 | B546VENDYS1 | JK-001V | VENDYS II | ENDOTHELIX, INC. | ||
23 | B510PM2000XLPRO1 | PM-2000XL PRO | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | ||
24 | B510PM2000XLPLUS1 | PM-2000XL PLUS | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | ||
25 | B510PM2000XL1 | PM-2000XL | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | ||
26 | B510PM2000TM1 | PM-2000TM | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | ||
27 | B510PM2000M1 | PM-2000M | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | ||
28 | B510PM2000APRO1 | PM-2000A PRO | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | ||
29 | B510PM2000A1 | PM-2000A | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | ||
30 | B320VH120 | VH12 | Premier Heart MCG 12 Lead capture hardware. | Premier Heart MCG Model VH12 | PREMIER HEART, LLC | |
31 | 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 | |
32 | B320CF190 | CF19 | CF19 | Premier Heart MCG Model CF19 | Premier Heart MCG | PREMIER HEART, LLC |
33 | B273CEA0 | 2.1.xx | Cardiologs ECG analysis platform | Cardiologs Platform | CARDIOLOGS TECHNOLOGIES | |
34 | 80010939050027 | 14.0 | McKesson Cardiology Hemo | MCKESSON TECHNOLOGIES INC. | ||
35 | 80010939050010 | 13.2.1 | McKesson Cardiology Hemo | MCKESSON TECHNOLOGIES INC. | ||
36 | 80010939040028 | 14.0 | McKesson Cardiology ECG Management | MCKESSON TECHNOLOGIES INC. | ||
37 | 80010939040011 | 13.2.1 | McKesson Cardiology ECG Management | MCKESSON TECHNOLOGIES INC. | ||
38 | 20884838072248 | Flow Sensor Neonatal | 989803144671 | The M2786A in combination with the spirometry module M1014A is designed to allow The M2786A in combination with the spirometry module M1014A is designed to allow measurement of airway pressures, flow, minute volume, tidal volume, airway compliance, airway resistance and CO2. | NA | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
39 | 20884838028726 | 989803179611 | 989803179611 | Genius 2 Probe Cover (CE marked) | Genius 2 | PHILIPS MEDICAL SYSTEMS HSG |
40 | 20857553006072 | M300-5 | M300-5 | Stealth System Wearable Sensor (M300). | Stealth System S300 | CARDIAC INSIGHT, INC. |
41 | 19351315000031 | XCEL | Packaged SphygmoCor XCEL systems including assembly module EM4 with UDI Direct M Packaged SphygmoCor XCEL systems including assembly module EM4 with UDI Direct Marking plus various components (SphygmoCor XCEL software DVD, product information DVD, tonometer, power cord/adapter, BP cuffs, and others).CONFIGURATIONS ENCOMPASSED BY THE XCEL VERSION/MODEL:• XCEL-PWA Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) only].• XCEL-PWV Configuration: [SphygmoCor software configured for pulse wave velocity (PWV) only].• XCEL-PWA+PWV Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) and pulse wave velocity (PWV)]. | SphygmoCor | ATCOR MEDICAL PTY LTD | |
42 | 19351315000017 | CVMS | Packaged SphygmoCor CVMS systems including assembly module EM3 with UDI Direct M Packaged SphygmoCor CVMS systems including assembly module EM3 with UDI Direct Marking plus various components [SphygmoCor CVMS software CD, tonometer, power cord/adapter, ECG pads/leads/cables (CPV configuration only), footswitch, and others].CONFIGURATIONS ENCOMPASSED BY THE CVMS VERSION/MODEL:• CvMS-CP Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) only].• CvMS-CPV Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) and pulse wave velocity (PWV)]• CvMS-CPVH Configuration: [SphygmoCor software configured for pulse wave analysis (PWA), pulse wave velocity (PWV) and Heart Rate Variability (HRV)]. | SphygmoCor | ATCOR MEDICAL PTY LTD | |
43 | 17540262120028 | 1.3 | Change Healthcare Cardiology ECG Mobile | CHANGE HEALTHCARE ISRAEL LTD | ||
44 | 17540262120011 | 1.2.4 | Change Healthcare Cardiology ECG Mobile | CHANGE HEALTHCARE ISRAEL LTD | ||
45 | 17540262110104 | 15.0.1 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE CANADA COMPANY | ||
46 | 17540262110098 | 15.0 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE CANADA COMPANY | ||
47 | 17540262110050 | 14.3.2 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE CANADA COMPANY | ||
48 | 17540262110043 | 14.3 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE CANADA COMPANY | ||
49 | 17540262110036 | 14.2 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE CANADA COMPANY | ||
50 | 17540262110029 | 14.1.1 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE ISRAEL LTD |