| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 15420045515031 | 2050-0104 | 2050-0104 | MWP | Cabinet, x-ray system | 2 | FAXITRON PATH | |
| 2 | 15420045514089 | R15 | R15 | GDF | GUIDE, NEEDLE, SURGICAL | 1 | PERL | |
| 3 | 15420045506909 | Discovery C | KGI | Densitometer, bone | 2 | Discovey C | ||
| 4 | 15420045504110 | ATEC Sapphire 200 | KNW | INSTRUMENT, BIOPSY | 2 | ATEC Sapphire 200 | ||
| 5 | 15420045510333 | 50-250XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MYOSURE XL HYSTEROSCOPY SET | ||
| 6 | 15420045514294 | V5 | NSV5US-001 | MNB | Device, thermal ablation, endometrial | 3 | NovaSure | |
| 7 | 25420045510330 | 50-250XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MYOSURE XL HYSTEROSCOPY SET | ||
| 8 | 25420045514307 | V5 | NSV5KITUS-001 | MNB | Device, thermal ablation, endometrial | 3 | NovaSure | |
| 9 | 25420045505107 | 40-902 | 40-902 | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MyoSure Tissue Removal Device | |
| 10 | 15420045514836 | PATHVISION 23x29 | PATHVISION23X29 | MWP | Cabinet, x-ray system | 2 | FAXITRON PATH | |
| 11 | 15420045514300 | V5 | NSV5KITUS-001 | MNB | Device, thermal ablation, endometrial | 3 | NovaSure | |
| 12 | 15420045512924 | INTERNAL CONTROL-B, 960T, IVD | PRD-06234 | JJH | CLINICAL SAMPLE CONCENTRATOR | 1 | Panther Fusion | |
| 13 | 15420045512917 | EXTRACTION REAGENTS-B, 960T, IVD | PRD-06232 | JJH | CLINICAL SAMPLE CONCENTRATOR | 1 | Panther Fusion | |
| 14 | 15420045510906 | GBS CTRLS KIT, PANTHER FUSION, IVD | PRD-04485 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
| 15 | 15420045510890 | GBS KIT, 96T, IVD | PRD-04484 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
| 16 | 15420045510470 | INTERNAL CONTROL-X, 960T, IVD | PRD-04476 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
| 17 | 15420045510463 | EXTRACTION REAGENT-X, 960T, IVD | PRD-04477 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
| 18 | 15420045509641 | System Software | InSight FD | OXO | Image-intensified fluoroscopic x-ray system, mobile | 2 | Flouroscan InSight | |
| 19 | 15420045509375 | CLASS I CONTROL - C. ALBICANS | PRD-04521 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | aptima | |
| 20 | 15420045507937 | 20-401ML | 20-401ML | NWW | Hysteroscope accessories | Myosure Manual Tissue Removal Device | ||
| 21 | 15420045505230 | B90003 | B90003 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | 4.0-5.0 CM CT LUMEN MARKER SET | |
| 22 | 15420045505193 | B11245 | B11245 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | 4-5 CM CONTURAFLEX MLB CATHETER w/TRI INTRODUCER | |
| 23 | 15420045505094 | 50-501XL | 50-501XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | MyoSure Tissue Removal Device | ||
| 24 | 15420045505087 | 50-401XL | 50-401XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MyoSure Tissue Removal Device | |
| 25 | 15420045505070 | 30-401LITE | 30-401LITE | HIH | HYSTEROSCOPE (AND ACCESSORIES) | MyoSure Tissue Removal Device | ||
| 26 | 15420045505001 | 919007-01 | 919007-01 | JAQ | System, applicator, radionuclide, remote-controlled | Mammosite Variable 4-5 cm Applicator Tray | ||
| 27 | 15420045504998 | EVIVA_1213-20 | EVIVA_1213-20 | KNW | INSTRUMENT, BIOPSY | EVIVA_1213-20 | ||
| 28 | 15420045504950 | EVIVA_0910-20 | EVIVA_0910-20 | KNW | INSTRUMENT, BIOPSY | EVIVA_0910-20 | ||
| 29 | 15420045504813 | 10-401 | 10-401 | HIH | HYSTEROSCOPE (AND ACCESSORIES) | MyoSure Tissue Removal Device | ||
| 30 | 15420045501140 | 2000 | NS2000US | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure | ||
| 31 | 15420045501133 | 2007 | NS2007US | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure SureSound | ||
| 32 | 15420045501126 | 2013 | NS2013KITUS | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure SureSound | ||
| 33 | 15420045501119 | 2013 | NS2013US | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure | ||
| 34 | 15420045501065 | Cervista HTA System Computer | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | Cervista HTA System | ||
| 35 | 15420045500969 | Cervista HTA System | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | Cervista HTA System | ||
| 36 | 15420045500952 | Cervista HTA System | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | Cervista HTA System | ||
| 37 | 15420045500860 | NovaSure Controller | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | 3 | NovaSure | ||
| 38 | 15420045500853 | NovaSure Controller | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | 3 | NovaSure | ||
| 39 | 15420045512474 | GENIUS AI DETECTION SOFTWARE | OTE | Digital breast tomosynthesis | 3 | GENIUS AI DETECTION | ||
| 40 | 25420045510064 | FILTER, THINPREP UROCYTE 100 PACK | 70472-001 | KET | FILTERS, CELL COLLECTION, TISSUE PROCESSING | ThinPrep | ||
| 41 | 25420045510057 | THINPREP SLIDES UROCYTE, 100 pk | 70471-001 | KEW | SLIDES, MICROSCOPE | ThinPrep | ||
| 42 | 25420045509990 | THINPREP MICROSCOPE, ARCLESS, 72pk | 70126-002 | KEW | SLIDES, MICROSCOPE | ThinPrep | ||
| 43 | 25420045509679 | NON-GYN Slides | 70372-001 | KEW | SLIDES, MICROSCOPE | ThinPrep | ||
| 44 | 25420045509662 | NON-GYN Filters, 100 pack | 70205-001 | KET | FILTERS, CELL COLLECTION, TISSUE PROCESSING | ThinPrep | ||
| 45 | 25420045508467 | UroCyte Vial | 70473-001 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
| 46 | 25420045505039 | 819001 | 819001 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Neucletron HDR Afterloader Connectors wObturators | |
| 47 | 15420045514775 | PRESERVCYT VIAL | PRD-07129 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
| 48 | 15420045514621 | UroCyte Vial | ASY-15509 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
| 49 | 15420045514614 | CytoLyt Cup | PRD-07065 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
| 50 | 15420045514607 | CytoLyt Tube | PRD-07064 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00842000101031 | 6.4 | Standalone Software Application | CADstream | MERGE HEALTHCARE SOLUTIONS INC. | |
| 2 | 00842000101024 | 9.0 | Correcting entry. | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | |
| 3 | 00842000101017 | 8.2 | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 4 | 00842000100980 | 8.1 | IBM iConnect Access 8.1 | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 5 | 00842000100935 | 8.2 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 6 | 00842000100928 | 12.1 | Standalone software application | Merge Cardio | MERGE HEALTHCARE SOLUTIONS INC. | |
| 7 | 00842000100881 | 6.3 | Standalone Software Application | CADstream | MERGE HEALTHCARE SOLUTIONS INC. | |
| 8 | 00842000100867 | 4.3 | Standalone software application | eFilm Lite | MERGE HEALTHCARE SOLUTIONS INC. | |
| 9 | 00842000100850 | 4.3 | Standalone software application | eFilm Workstation | MERGE HEALTHCARE SOLUTIONS INC. | |
| 10 | 00842000100843 | 7.2 | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 11 | 00842000100829 | 13.0 | Merge Unity PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 12 | 00842000100805 | 8.1 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 13 | 00842000100782 | 7.1 | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 14 | 00842000100775 | 8.0 | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 15 | 00842000100768 | 12.0.1 | Merge Cardio | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 16 | 00842000100751 | 11.1 | Merge Cardio V11.1 | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 17 | 00842000100744 | 12.0 | Merge Unity PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 18 | 00842000100737 | 8.0 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 19 | 00842000100720 | 7.0 | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 20 | 00842000100713 | 3.7.5 | Merge OrthoCase | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 21 | 00842000100706 | 7.3 | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 22 | 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.). | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 23 | 00842000100683 | 6.5 | Stand alone software application. | iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | |
| 24 | 00842000100676 | 7.2 | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 25 | 00842000100652 | 4.2.1 | eFilm Workstation | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 26 | 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. | Merge iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | |
| 27 | 00842000100638 | 6.2 | Standalone Software Application | CADstream | MERGE HEALTHCARE SOLUTIONS INC. | |
| 28 | 00842000100614 | 8.32 | RadSuite | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 29 | 00842000100607 | 7.1.0 | Standalone software application | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 30 | 00842000100591 | 10.1 | Standalone software application | Merge Cardio | MERGE HEALTHCARE SOLUTIONS INC. | |
| 31 | 00842000100577 | 7.0.2 | Standalone software application | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 32 | 00842000100560 | 7.0.2 | Standalone software application | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 33 | 00842000100508 | 6.6.3.2 | Standalone software application | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 34 | 00842000100478 | 7.1.2.1 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 35 | 00842000100461 | 11.0 | Merge Unity Pacs | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 36 | 00842000100454 | 7.1.2.1 | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 37 | 00842000100416 | 11.0 | Standalone software application | Merge Cardio | MERGE HEALTHCARE SOLUTIONS INC. | |
| 38 | 00842000100409 | 7.2 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 39 | 00842000100348 | 6.6.3.2 | Standalone software application | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 40 | 00842000100331 | 11.2 | Standalone software application | Merge Unity PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 41 | 00842000100300 | 4.2.1 | eFilm Lite | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 42 | 00842000100294 | 4.2 | Standalone software application | eFilm Lite | MERGE HEALTHCARE SOLUTIONS INC. | |
| 43 | 00842000100287 | 4.2 | Standalone software application | eFilm Workstation | MERGE HEALTHCARE SOLUTIONS INC. | |
| 44 | 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. | iConnect Enterprise Workflow with Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 45 | 00842000100126 | 6.3 | Standalone software application. | Merge iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | |
| 46 | 00842000100089 | 7.1.1 | Standalone software application. | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 47 | 00842000100072 | 7.1.1 | Standalone software application | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 48 | 00842000100065 | 2.0 | Stand alone software application. | Merge Z3D | MERGE HEALTHCARE SOLUTIONS INC. | |
| 49 | 00842000100058 | 11.1.2 | Standalone software application | Merge Unity PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 50 | 00842000100041 | 10.3 | Standalone software application. | Merge Cardio | MERGE HEALTHCARE SOLUTIONS INC. |