| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00840241600047 | 80014-001 | 80014-001 | The ASSURE Wearable Cardioverter Defibrillator System | MVK | Wearable Automated External Defibrillator | 3 | ASSURE WCD System |
| 2 | 00840241600160 | 80016-005 | 80016-005 | The Style B, Size 5, ASSURE Garment is a fabric top that contains Sensors that t The Style B, Size 5, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style B, Size 5 |
| 3 | 00840241600153 | 80016-004 | 80016-004 | The Style B, Size 4, ASSURE Garment is a fabric top that contains Sensors that t The Style B, Size 4, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style B, Size 4 |
| 4 | 00840241600108 | 80015-006 | 80015-006 | The Style A, Size 6, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 6, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style A, Size 6 |
| 5 | 00840241600061 | 80015-002 | 80015-002 | The Style A, Size 2, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 2, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style A, Size 2 |
| 6 | 00840241600184 | 80016-007 | 80016-007 | The Style B, Size 7, ASSURE Garment is a fabric top that contains Sensors that t The Style B, Size 7, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style B, Size 7 |
| 7 | 00840241600177 | 80016-006 | 80016-006 | The Style B, Size 6, ASSURE Garment is a fabric top that contains Sensors that t The Style B, Size 6, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style B, Size 6 |
| 8 | 00840241600146 | 80016-003 | 80016-003 | The Style B, Size 3, ASSURE Garment is a fabric top that contains Sensors that t The Style B, Size 3, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style B, Size 3 |
| 9 | 00840241600054 | 80015-001 | 80015-001 | The Style A, Size 1, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 1, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style A, Size 1 |
| 10 | 00840241600269 | 80433-002 | 80433-002 | CareStation Server acquires and displays data from the WCD for clinicians to view. | OUG | Medical Device Data System | 1 | CareStation Server |
| 11 | 00840241600191 | 80041-001 | 80041-001 | An electronic device used to program the ASSURE system and assist in patient fit An electronic device used to program the ASSURE system and assist in patient fitting and training | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Tablet |
| 12 | 00840241600122 | 80016-001 | 80016-001 | The Style B, Size 1, ASSURE Garment is a fabric top that contains Sensors that t The Style B, Size 1, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style B, Size 1 |
| 13 | 00840241600023 | 80004-003 | 80004-003 | Provides the connection between the Garment and the Monitor | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Therapy Cable |
| 14 | 00840241600207 | 3326502-003 | 3326502-003 | A portable case that holds the Monitor while wearing the ASSURE system | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Carry Pack |
| 15 | 00840241600139 | 80016-002 | 80016-002 | The Style B, Size 2, ASSURE Garment is a fabric top that contains Sensors that t The Style B, Size 2, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style B, Size 2 |
| 16 | 00840241600092 | 80015-005 | 80015-005 | The Style A, Size 5, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 5, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style A, Size 5 |
| 17 | 00840241600085 | 80015-004 | 80015-004 | The Style A, Size 4, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 4, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style A, Size 4 |
| 18 | 00840241600252 | 80429-003 | 80429-003 | ASSURE patient app is a component of CareStation. | OUG | Medical Device Data System | 1 | ASSURE Patient Application |
| 19 | 00840241600016 | 3326633-004 | 3326633-004 | A separate device that charges the Battery | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Charger |
| 20 | 00840241600115 | 80015-007 | 80015-007 | The Style A, Size 7, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 7, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style A, Size 7 |
| 21 | 00840241600078 | 80015-003 | 80015-003 | The Style A, Size 3, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 3, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style A, Size 3 |
| 22 | 00840241600030 | 80008-003 | 80008-003 | A part of the ASSURE System that provides power and displays system status information | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Monitor |
| 23 | 00840241600009 | 3322882-005 | 3322882-005 | A rechargeable battery that powers the ASSURE System | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Battery |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 10884521795150 | VDASHSUBEXS01 | Ventilation Dashboard v1.0 Excess Use Subscription | Vital Sync | COVIDIEN LP | |
| 2 | 10884521795143 | VDASHSUB01 | Ventilation Dashboard v1.0 Subscription | Vital Sync | COVIDIEN LP | |
| 3 | 10884521706675 | SBTWR v1.0 | Spontaneous Breathing Trial and Weaning Readiness Application v1.0 | Vital Sync | COVIDIEN LP | |
| 4 | 10884521706668 | EWS v1.0 | Early Warning Score Application v1.0 | Vital Sync | COVIDIEN LP | |
| 5 | 10841522125003 | 96190 | 1.X.X | XPREZZNET,96190 | Xprezznet | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 6 | 10841522123658 | 92848 | 5.x.x | ENTERPRISE NETWORK INTERFACE,92848 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 7 | 10841522123641 | 92843 | 5.x.x | HL7 VITAL SIGNS INTERFACE,92843 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 8 | 10841522123634 | 92842 | 5.x.x | HL7,ADT INTERFACE,92842 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 9 | 10841522123610 | 92880 | 5.x.x | VITAL SIGNS VIEWER,92880 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 10 | 10841522123603 | 92877 | 5.x.x | 12 LEAD ECG INTERFACE,92877 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 11 | 10841522104558 | 94267 | Sentinel | SPACELABS HEALTHCARE (WASHINGTON), INC | ||
| 12 | 10841522104541 | 94267 | XPREZZON and qube Display Options | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | |
| 13 | 10841522100192 | 96190 | 1.3.1 | Spacelabs Network Interface | Xprezznet | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 14 | 10841522100178 | 92880 | V5.2.3 | VITAL SIGNS VIEWER,92880 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 15 | 10841522100161 | 92877 | V5.2.3 | 12 LEAD ECG INTERFACE,92877 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 16 | 10841522100154 | 92876 | V5.2.3 | CUSTOM TRENDS,92876 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 17 | 10841522100147 | 92848 | V5.2.3 | ENTERPRISE NETWORK INTERFACE,92848 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 18 | 10841522100130 | 92843 | V5.2.3 | HL7 VITAL SIGNS INTERFACE,92843 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 19 | 10841522100123 | 92842 | V5.2.3 | HL7,ADT INTERFACE,92842 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 20 | M58802000780030 | DMS-100 | 020-007800-3 | The Odyssey Workstation is an optional display and user interface package design The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab | Cinema MAS & MMS | STEREOTAXIS, INC. |
| 21 | M58800100790010 | Link | 001-007900-1 | The Odyssey Workstation is an optional display and user interface package design The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab | Odyssey | STEREOTAXIS, INC. |
| 22 | M58800100784010 | Studio | 001-007840-1 | The Odyssey Workstation is an optional display and user interface package design The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab | Odyssey Cinema | STEREOTAXIS, INC. |
| 23 | M58800100781010 | EIF | 001-007810-1 | The Odyssey Workstation is an optional display and user interface package design The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab | Odyssey Enterprise Interface | STEREOTAXIS, INC. |
| 24 | 09420012424266 | 900ICON203 | 900ICON203 | F&P InfoUSB | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED |
| 25 | 09352527001192 | VFPROEX24.03 | ProEX Telehealth Hub System FSC2 - NTSC - CLIN - v3 | Visionflex | VISIONFLEX PTY. LTD. | |
| 26 | 09352527001185 | VFPROEX23.03 | ProEX Telehealth Hub System GEIS - CLIN - v3 | Visionflex | VISIONFLEX PTY. LTD. | |
| 27 | 09352527001161 | VFPROEX21.03 | ProEX Telehealth Hub System Standard - CLIN - v3 | Visionflex | VISIONFLEX PTY. LTD. | |
| 28 | 09352527000669 | VFPROEXMOBILE1.01 | ProEX Mobile Telehealth Hub | Visionflex | VISIONFLEX PTY. LTD. | |
| 29 | 09352527000614 | VFPROEX21.03 | ProEX Telehealth Hub System Standard - CLINICIAN v3 | Visionflex | VISIONFLEX PTY. LTD. | |
| 30 | 09352527000607 | VFPROEX26.02 | ProEX Telehealth Hub System FSC3 CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. | |
| 31 | 09352527000591 | VFPROEX25.02 | ProEX Telehealth Hub System FSC2 CUSTOMER SUPPLIED - CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. | |
| 32 | 09352527000584 | VFPROEX24.02 | ProEX Telehealth Hub System FSC2 - NTSC - CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. | |
| 33 | 09352527000577 | VFPROEX23.02 | ProEX Telehealth Hub System GEIS - CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. | |
| 34 | 09352527000560 | VFPROEX22.02 | ProEX Telehealth Hub System FSC2 PAL - CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. | |
| 35 | 09352527000553 | VFPROEX21.02 | The ProEX Imaging Hub is specifically designed and engineered to enable health p The ProEX Imaging Hub is specifically designed and engineered to enable health practitioners all over the world to confidently carry out detailed medical examinations on patients based in regional, remote, rural and urban areas. | Visionflex | VISIONFLEX PTY. LTD. | |
| 36 | 09350855000214 | N05007 | RFID Medical Instrument tag | trophon AcuTrace Medical Instrument Tag | NANOSONICS LIMITED | |
| 37 | 09350855000207 | N05006 | RFID Operator card | trophon AcuTrace Operator Card | NANOSONICS LIMITED | |
| 38 | 08714729975700 | M00420020620 | M00420020620 | LABSYSTEM™ PRO EP Review Workstation Software | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION |
| 39 | 08714729884002 | M00420020300 | LABSYSTEM™ PRO EP Review Workstation Software, V2.7 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | |
| 40 | 08437014572308 | 1006 | KIRO Link is a software intended to store, convert formats, transfer and display KIRO Link is a software intended to store, convert formats, transfer and display the medical data required for the integration and workflow management functionalities of compounding associated technologies. These technologies include customer site software (Computerized Physician Order Entry (CPOE), logistics, quality control, etc.), Pharmacy Compounding Devices (PCDs) and compounding assisting software. The software is intended to be used only by qualified pharmacy personnel. | KIRO Link | KIRO GRIFOLS SL. | |
| 41 | 08052286590173 | EI KT0 0005 521 | Echolaser Smart Interface (ESI) and its accessories | Echolaser Smart Interface (ESI) | ELESTA SPA | |
| 42 | 08033737713037 | THD Procto Software | 760004 | The THD Procto Software System is a diagnostic system intended to be used to inv The THD Procto Software System is a diagnostic system intended to be used to investigatepelvic floor disorders, and specifically the THD Procto Software together with its accessories and devices (endoanal probe, video camera and THD Anopress), is able to be applied for:- Endoanal ultrasound (trans-rectal ultrasound / echography)- Anoscopy exams- Manometry exams | THD Procto Software System | THD SPA |
| 43 | 07613327505245 | 0101-2200 | 0101-2200 | Digital Port Connector | ADAPT | STRYKER LEIBINGER GMBH & CO. KG |
| 44 | 07613327482690 | 9222110000 | 9222-110-000 | System 9 Non-Sterile Battery, Small | N/A | STRYKER CORPORATION |
| 45 | 07613327482652 | 9126110000 | 9126-110-000 | System 9 Non-Sterile Battery, Large | N/A | STRYKER CORPORATION |
| 46 | 07613327467888 | 4608000000 | 4608-000-000 | System 9 Sagittal Saw | Sabo | STRYKER CORPORATION |
| 47 | 07613327467871 | 4605000000 | 4605-000-000 | System 9 Cordless Driver Handpiece | NA | STRYKER CORPORATION |
| 48 | 07613327467864 | 9209000000 | 9209-000-000 | System 9 Stryker Saw | Precision | STRYKER CORPORATION |
| 49 | 07613327467857 | 9208000000 | 9208-000-000 | System 9 Sagittal Saw | NA | STRYKER CORPORATION |
| 50 | 07613327467840 | 9207000000 | 9207-000-000 | System 9 Sternum Saw | NA | STRYKER CORPORATION |