| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00842000100751 | 11.1 | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio V11.1 | ||
| 2 | 00842000100980 | 8.1 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access 8.1 | ||
| 3 | 00842000100010 | 10.0.4 | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo | ||
| 4 | 00842000100133 | 1.0 | Standalone software application. A universal workflow (non-medical tool) on Merg Standalone software application. A universal workflow (non-medical tool) on Merge PACS platform. | LLZ | System, Image Processing, Radiological | 2 | iConnect Enterprise Workflow with Merge PACS | |
| 5 | 00842000100126 | 6.3 | Standalone software application. | LLZ | System, Image Processing, Radiological | 2 | Merge iConnect Access | |
| 6 | 00842000100966 | 10.4 | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo | ||
| 7 | 00842000100683 | 6.5 | Stand alone software application. | LLZ | System, Image Processing, Radiological | 2 | iConnect Access | |
| 8 | 00842000100645 | 6.4 | Software application that provides internet access to multi-modality softcopy me Software application that provides internet access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data. | LLZ | System, Image Processing, Radiological | 2 | Merge iConnect Access | |
| 9 | 00842000100447 | 11.0 | Correcting entry. | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo | |
| 10 | 00842000100072 | 7.1.1 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 11 | 00842000100058 | 11.1.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Unity PACS | |
| 12 | 00842000100409 | 7.2 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 13 | 00842000100829 | 13.0 | LLZ | System, Image Processing, Radiological | 2 | Merge Unity PACS | ||
| 14 | 00842000100805 | 8.1 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 15 | 00842000100331 | 11.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Unity PACS | |
| 16 | 00842000100935 | 8.2 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 17 | 00842000100690 | 7.3 | Merge PACS™ is a standards-based medical imaging diagnostic workstation that ser Merge PACS™ is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings. Merge PACS processes and displays medical images from DICOM-compliant modalities. The device is designed to enable efficient workflows by maintaining clinicians’ worklists and retrieving and managing studies for reading, reporting, communication, and storage.Merge PACS software runs on off-the-shelf computer hardware and can be configured to operate standalone or to integrate with vendor-neutral imaging archives (VNAs) such as iConnect Enterprise Archive (iCEA) for image storage, and with radiological and hospital information systems (RIS and HIS) and medical record systems (EMR, EHR, etc.). | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 18 | 00842000100607 | 7.1.0 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 19 | 00842000100560 | 7.0.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 20 | 00842000100508 | 6.6.3.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 21 | 00842000100478 | 7.1.2.1 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 22 | 00842000100461 | 11.0 | LLZ | System, Image Processing, Radiological | 2 | Merge Unity Pacs | ||
| 23 | 00842000100089 | 7.1.1 | Standalone software application. | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | |
| 24 | 00842000100034 | 10.1 | DQK | Computer, Diagnostic, Programmable | 2 | Merge HEMO | ||
| 25 | 00842000100348 | 6.6.3.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | |
| 26 | 00842000100706 | 7.3 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 27 | 00842000100775 | 8.0 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 28 | 00842000100676 | 7.2 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 29 | 00842000100577 | 7.0.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | |
| 30 | 00842000100454 | 7.1.2.1 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 31 | 00842000100737 | 8.0 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 32 | 00842000100614 | 8.32 | LLZ | System, Image Processing, Radiological | 2 | RadSuite | ||
| 33 | 00842000100515 | 77-00327-00 | Merge Hemo 77-00327-00 Link Assembly | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo Link Assembly | |
| 34 | 00842000100041 | 10.3 | Standalone software application. | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio | |
| 35 | 00842000100003 | 7.0 | Standalone Software Application | LLZ | System, Image Processing, Radiological | 2 | CADstream | |
| 36 | 90842000100914 | 8.0 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 37 | 00842000100782 | 7.1 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 38 | 00842000100720 | 7.0 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 39 | 00842000101031 | 6.4 | Standalone Software Application | LLZ | System, Image Processing, Radiological | 2 | CADstream | |
| 40 | 00842000101024 | 9.0 | Correcting entry. | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | |
| 41 | 00842000101017 | 8.2 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 42 | 00842000100928 | 12.1 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio | |
| 43 | 00842000100881 | 6.3 | Standalone Software Application | LLZ | System, Image Processing, Radiological | 2 | CADstream | |
| 44 | 00842000100638 | 6.2 | Standalone Software Application | LLZ | System, Image Processing, Radiological | 2 | CADstream | |
| 45 | 00842000100591 | 10.1 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio | |
| 46 | 00842000100416 | 11.0 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio | |
| 47 | 00842000100300 | 4.2.1 | LLZ | System, Image Processing, Radiological | 2 | eFilm Lite | ||
| 48 | 00842000100065 | 2.0 | Stand alone software application. | LLZ | System, Image Processing, Radiological | 2 | Merge Z3D | |
| 49 | 00842000100867 | 4.3 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | eFilm Lite | |
| 50 | 00842000100850 | 4.3 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | eFilm Workstation |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00850022994173 | Merge 3.5mm, Type I | 512-134 | Zurich Medical Accessory Cable | ZURICH MEDICAL INC. | |
| 2 | 00850022994166 | Merge 3.5mm, Type G | 512-133 | Zurich Medical Accessory Cable | ZURICH MEDICAL INC. | |
| 3 | 00850022994159 | Merge 3.5mm, Type C | 512-132 | Zurich Medical Accessory Cable | ZURICH MEDICAL INC. | |
| 4 | 00850022994142 | Merge 3.5mm, Type A | 512-131 | Zurich Medical Accessory Cable | ZURICH MEDICAL INC. | |
| 5 | 00850022994128 | GE 9-Pin, Type I | 512-024 | Zurich Medical Accessory Cable | ZURICH MEDICAL INC. | |
| 6 | 00850022994111 | GE 9-Pin, Type G | 512-023 | Zurich Medical Accessory Cable | ZURICH MEDICAL INC. | |
| 7 | 00850022994104 | GE 9-Pin, Type C | 512-022 | Zurich Medical Accessory Cable | ZURICH MEDICAL INC. | |
| 8 | 00850022994098 | GE 9-Pin, Type A | 512-021 | Zurich Medical Accessory Cable | ZURICH MEDICAL INC. | |
| 9 | 00850022994081 | Philips BNC, Type I | 512-124 | Zurich Medical Accessory Cable | ZURICH MEDICAL INC. | |
| 10 | 00850022994074 | Philips BNC, Type G | 512-123 | Zurich Medical Accessory Cable | ZURICH MEDICAL INC. | |
| 11 | 00850022994067 | Philips BNC, Type C | 512-122 | Zurich Medical Accessory Cable | ZURICH MEDICAL INC. | |
| 12 | 00850022994050 | Philips BNC, Type A | 512-121 | Zurich Medical Accessory Cable | ZURICH MEDICAL INC. | |
| 13 | 00850022994043 | GE 7-Pin, Type I | 512-004 | Zurich Medical Accessory Cable | ZURICH MEDICAL INC. | |
| 14 | 00850022994036 | GE 7-Pin, Type G | 512-003 | Zurich Medical Accessory Cable | ZURICH MEDICAL INC. | |
| 15 | 00850022994029 | GE-7-Pin, Type C | 512-002 | Zurich Medical Accessory Cable | ZURICH MEDICAL INC. | |
| 16 | 00850022994012 | GE-7-Pin, Type A | 512-001 | Zurich Medical Accessory Cable | ZURICH MEDICAL INC. | |
| 17 | 00850022994005 | Model 100 | 308 | Zurich Pressure Guidewire System | ZURICH MEDICAL INC. | |
| 18 | 00843152104000 | SW-1 | SW-1 | The IOPS (Intra-Operative Positioning System) is intended for the evaluation of The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis. | IOPS™ Software Application | CENTERLINE BIOMEDICAL, INC. |
| 19 | 00843152103003 | TP-1 | TP-1 | IOPS™ Tracking Pad 1 | IOPS™ | CENTERLINE BIOMEDICAL, INC. |
| 20 | 00843152102037 | ATW-2 | ATW-2 | IOPS™ Guidewire 2 | IOPS™ | CENTERLINE BIOMEDICAL, INC. |
| 21 | 00843152102013 | SSH-1 | SSH-1 | IOPS™ Guidewire 2 Handle for connection of guidewire sensor to system | IOPS™ | CENTERLINE BIOMEDICAL, INC. |
| 22 | 00843152101030 | RCC-1 | RCC-1 | IOPS™ Catheter Reverse Curve 1 | IOPS™ | CENTERLINE BIOMEDICAL, INC. |
| 23 | 00843152101023 | SCC-1 | SCC-1 | IOPS™ Catheter Simple Curve 1 | IOPS™ | CENTERLINE BIOMEDICAL, INC. |
| 24 | 00843152100002 | MC-1 | MC-1 | The IOPS (Intra-Operative Positioning System) is intended for the evaluation of The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis. | IOPS Mobile Cart | CENTERLINE BIOMEDICAL, INC. |
| 25 | 00842000100966 | 10.4 | Merge Hemo | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 26 | 00842000100874 | 10.3 | Merge Hemo | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 27 | 00842000100515 | 77-00327-00 | Merge Hemo 77-00327-00 Link Assembly | Merge Hemo Link Assembly | MERGE HEALTHCARE SOLUTIONS INC. | |
| 28 | 00842000100447 | 11.0 | Correcting entry. | Merge Hemo | MERGE HEALTHCARE SOLUTIONS INC. | |
| 29 | 00842000100430 | 10.2 | Merge Hemo | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 30 | 00842000100034 | 10.1 | Merge HEMO | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 31 | 00842000100027 | 9.4 | Merge Hemo | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 32 | 00842000100010 | 10.0.4 | Merge Hemo | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 33 | 00841268100541 | SGW-011-08 | SGW-011-08 | Guidewire | Guidewire | GALT MEDICAL CORP. |
| 34 | 00840682188968 | BT21 | MLCL Upgrade | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | ||
| 35 | 00840682152754 | NotifyMe V1.0 | MD ACUTE VIRTUAL COLLABORATOR NOTIFY ME 1.0 | Graffiti | GE HEALTHCARE | |
| 36 | 00840682147224 | B125P VSP3.0 Patient Monitor | 6160000-002 | B125P ATO MODEL | NA | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
| 37 | 00840682147217 | B105P VSP3.0 Patient Monitor | 6160000-001 | B105P ATO MODEL | NA | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
| 38 | 00840682146791 | B155 VSP3.0 Patient Monitor | 6160000-005 | B155M ATO MODEL | NA | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
| 39 | 00840682146715 | B125 VSP3.0 Patient Monitor | 6160000-004 | B125M ATO MODEL | NA | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
| 40 | 00840682146708 | B105 VSP3.0 Patient Monitor | 6160000-003 | B105M ATO MODEL | NA | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
| 41 | 00840682146142 | MBC323 | 5805690 | CARESCAPE B850 MBC323 (ATO MODEL) | CARESCAPE B850 | GE HEALTHCARE FINLAND OY |
| 42 | 00840682146135 | MBA323 | 5805686 | CARESCAPE B450 MBA323 (ATO MODEL) | CARESCAPE B450 | GE HEALTHCARE FINLAND OY |
| 43 | 00840682146111 | MBB323 | 5805688 | CARESCAPE B650 MBB323 (ATO MODEL) | CARESCAPE B650 | GE HEALTHCARE FINLAND OY |
| 44 | 00840682146029 | A1 | ComboLab | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | ||
| 45 | 00840682146012 | A1 | CardioLab | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | ||
| 46 | 00840682145985 | A1 | Computer Mac-Lab Acquisition v7.0 | Mac-Lab | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | |
| 47 | 00840682145763 | A1 | GE Client Software | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | ||
| 48 | 00840682145756 | A1 | INW Server | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | ||
| 49 | 00840682144308 | MBC313 | CARESCAPE B850 MBC313 (ATO MODEL) | CARESCAPE B850 | GE HEALTHCARE FINLAND OY | |
| 50 | 00840682143806 | MBB313 | CARESCAPE B650 MBB313 (ATO MODEL) | CARESCAPE B650 | GE HEALTHCARE FINLAND OY |