| 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 | 07332940002350 | GXCT/NG-120 | GXCT/NG-120 | Xpert CT/NG kit; 120 test kit | Xpert CT/NG | CEPHEID |
| 2 | 07332940002350 | GXCT/NG-120 | GXCT/NG-120 | Xpert CT/NG kit; 120 test kit | Xpert CT/NG | CEPHEID |
| 3 | 07332940000080 | GXCT/NG-10 | GXCT/NG-10 | Xpert CT/NG kit; 10 test kit | Xpert CT/NG | CEPHEID |
| 4 | 07332940000080 | GXCT/NG-10 | GXCT/NG-10 | Xpert CT/NG kit; 10 test kit | Xpert CT/NG | CEPHEID |
| 5 | 04053228010296 | 2 | 5140-1220 | digene® HC2 GC-ID DNA Test | QIAGEN SCIENCES INC. | |
| 6 | 04053228010265 | 2 | 5130-1220 | digene® HC2 CT/GC DNA Test | QIAGEN SCIENCES INC. | |
| 7 | 04015630929016 | 05200881001 | 05200881001 | cobas z 480 | ROCHE MOLECULAR SYSTEMS, INC. | |
| 8 | 04015630929016 | 05200881001 | 05200881001 | cobas z 480 | ROCHE MOLECULAR SYSTEMS, INC. | |
| 9 | 00884999049314 | 09N20-012 | 09N20-012 | Alinity m Bottle for Ethanol Use | Alinity m | ABBOTT MOLECULAR INC. |
| 10 | 00884999049314 | 09N20-012 | 09N20-012 | Alinity m Bottle for Ethanol Use | Alinity m | ABBOTT MOLECULAR INC. |
| 11 | 00884999049314 | 09N20-012 | 09N20-012 | Alinity m Bottle for Ethanol Use | Alinity m | ABBOTT MOLECULAR INC. |
| 12 | 00884999048898 | 09N19-012 | 09N19-012 | Alinity m | ABBOTT MOLECULAR INC. | |
| 13 | 00884999048898 | 09N19-012 | 09N19-012 | Alinity m | ABBOTT MOLECULAR INC. | |
| 14 | 00884999048898 | 09N19-012 | 09N19-012 | Alinity m | ABBOTT MOLECULAR INC. | |
| 15 | 00884999048669 | 1.00 | 09N17-03A | Alinity m STI Application Specification File | Alinity m | ABBOTT MOLECULAR INC. |
| 16 | 00884999048607 | 09N17-085 | 09N17-085 | Alinity m STI CTRL Kit | Alinity m | ABBOTT MOLECULAR INC. |
| 17 | 00884999048591 | 09N17-095 | 09N17-095 | Alinity m STI AMP Kit | Alinity m | ABBOTT MOLECULAR INC. |
| 18 | 00884999047693 | 09N20-002 | 09N20-002 | Alinity m Ethanol Solution | Alinity m | ABBOTT MOLECULAR INC. |
| 19 | 00884999047693 | 09N20-002 | 09N20-002 | Alinity m Ethanol Solution | Alinity m | ABBOTT MOLECULAR INC. |
| 20 | 00884999047693 | 09N20-002 | 09N20-002 | Alinity m Ethanol Solution | Alinity m | ABBOTT MOLECULAR INC. |
| 21 | 00884999047686 | 09N18-001 | 09N18-001 | Alinity m Sample Prep Kit 1 | Alinity m | ABBOTT MOLECULAR INC. |
| 22 | 00884999047686 | 09N18-001 | 09N18-001 | Alinity m Sample Prep Kit 1 | Alinity m | ABBOTT MOLECULAR INC. |
| 23 | 00884999047686 | 09N18-001 | 09N18-001 | Alinity m Sample Prep Kit 1 | Alinity m | ABBOTT MOLECULAR INC. |
| 24 | 00884999046528 | 9K12-04 | 9K12-04 | multi-Collect Specimen Collection Kit | Multi-Collect | ABBOTT MOLECULAR INC. |
| 25 | 00884999046528 | 9K12-04 | 9K12-04 | multi-Collect Specimen Collection Kit | Multi-Collect | ABBOTT MOLECULAR INC. |
| 26 | 00884999046511 | 9K12-03 | 9K12-03 | multi-Collect Specimen Collection Specimen Collection Kit | Multi-Collect | ABBOTT MOLECULAR INC. |
| 27 | 00884999046511 | 9K12-03 | 9K12-03 | multi-Collect Specimen Collection Specimen Collection Kit | Multi-Collect | ABBOTT MOLECULAR INC. |
| 28 | 00884999037472 | 06L87-02 | 06L87-02 | Uracil-N-Glycosylase (UNG) | RealTime | ABBOTT MOLECULAR INC. |
| 29 | 00884999037472 | 06L87-02 | 06L87-02 | Uracil-N-Glycosylase (UNG) | RealTime | ABBOTT MOLECULAR INC. |
| 30 | 00884999037410 | 8L07-67 | 8L07-67 | Abbott RealTime CT/NG Amplification Reagent Extended Use Including Uracil-N-Glyc Abbott RealTime CT/NG Amplification Reagent Extended Use Including Uracil-N-Glycosylase (UNG) | RealTime | ABBOTT MOLECULAR INC. |
| 31 | 00884999037410 | 8L07-67 | 8L07-67 | Abbott RealTime CT/NG Amplification Reagent Extended Use Including Uracil-N-Glyc Abbott RealTime CT/NG Amplification Reagent Extended Use Including Uracil-N-Glycosylase (UNG) | RealTime | ABBOTT MOLECULAR INC. |
| 32 | 00884999037298 | 8L07-50 | 8L07-50 | Abbott RealTime CT/NG Amplification Reagent Extended Use with Pierceable Caps | RealTime | ABBOTT MOLECULAR INC. |
| 33 | 00884999037298 | 8L07-50 | 8L07-50 | Abbott RealTime CT/NG Amplification Reagent Extended Use with Pierceable Caps | RealTime | ABBOTT MOLECULAR INC. |
| 34 | 00884999037113 | 06L98-05 | 06L98-05 | Abbott m2000 System Chlamydia trachomatis and Neisseria gonorrhoeae Application Abbott m2000 System Chlamydia trachomatis and Neisseria gonorrhoeae Application CD-ROM, Version 5.0 | RealTime | ABBOTT MOLECULAR INC. |
| 35 | 00884999037113 | 06L98-05 | 06L98-05 | Abbott m2000 System Chlamydia trachomatis and Neisseria gonorrhoeae Application Abbott m2000 System Chlamydia trachomatis and Neisseria gonorrhoeae Application CD-ROM, Version 5.0 | RealTime | ABBOTT MOLECULAR INC. |
| 36 | 00884999031142 | 8L07-91 | 8L07-91 | Abbott RealTime CT/NG Amplification Reagent Kit | RealTime | ABBOTT MOLECULAR INC. |
| 37 | 00884999031142 | 8L07-91 | 8L07-91 | Abbott RealTime CT/NG Amplification Reagent Kit | RealTime | ABBOTT MOLECULAR INC. |
| 38 | 00884999031128 | 8L07-80 | 8L07-80 | Abbott RealTime CT/NG Control Kit | RealTime | ABBOTT MOLECULAR INC. |
| 39 | 00884999031128 | 8L07-80 | 8L07-80 | Abbott RealTime CT/NG Control Kit | RealTime | ABBOTT MOLECULAR INC. |
| 40 | 00875197005783 | 07460082190 | 07460082190 | cobas CTNG Positive Control Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
| 41 | 00875197005783 | 07460082190 | 07460082190 | cobas CTNG Positive Control Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
| 42 | 00875197005776 | 07460066190 | 07460066190 | cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems | ROCHE MOLECULAR SYSTEMS, INC. | |
| 43 | 00875197005776 | 07460066190 | 07460066190 | cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems | ROCHE MOLECULAR SYSTEMS, INC. | |
| 44 | 00875197005738 | 07958021190 | 07958021190 | cobas PCR Media Dual Swab Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
| 45 | 00875197005738 | 07958021190 | 07958021190 | cobas PCR Media Dual Swab Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
| 46 | 00875197005721 | 07958030190 | 07958030190 | cobas® PCR Media Uni Swab Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
| 47 | 00875197005721 | 07958030190 | 07958030190 | cobas® PCR Media Uni Swab Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
| 48 | 00875197005363 | 2.0 | 07102577190 | cobas® 4800 CT/NG Test v2.0 | ROCHE MOLECULAR SYSTEMS, INC. | |
| 49 | 00875197005363 | 2.0 | 07102577190 | cobas® 4800 CT/NG Test v2.0 | ROCHE MOLECULAR SYSTEMS, INC. | |
| 50 | 00875197005356 | 2.0 | 07102569190 | cobas® 4800 CT/NG Test v2.0 | ROCHE MOLECULAR SYSTEMS, INC. |