No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00814247020727 | VPBB15014100 | BoogieBaby nasal aspirator – standard tip with cover | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – standard tip with cover | ||
2 | 00814247020680 | VPBB15011100 | BoogieBaby nasal aspirator – preemie tip | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – preemie tip | ||
3 | 00814247020444 | ROM-6000 | ROM Plus® Complete Kit Fetal Membranes Rupture Test | NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | 1 | ROM Plus®, Fetal Membranes Rupture Collection Kit | |
4 | 30814247020346 | PRS-0530 | Traxi Panniculus Retractor with Retentus Technology (BMI 30-50) | CCX | Support, Patient Position | traxi® Panniculus Retractorhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetai | ||
5 | 00814247020147 | DSD-2000 | ClearView accessory - Disposable Sound Dilator | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView | |
6 | 00814247020130 | DSD-1000 | Sound/Dilator (accessory for ClearView Uterine Manipulator) | LKF | Cannula, Manipulator/Injector, Uterine | ClearView | ||
7 | 00814247021083 | VPBB150112100 | BoogieBaby nasal aspirator – olive tip 4.5 inch long | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – olive tip 4.5 inch long | ||
8 | 00814247020734 | VPBB15015100 | BoogieBaby nasal aspirator – flair tip | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – flair tip | ||
9 | 00814247020697 | VPBB15012100 | BoogieBaby nasal aspirator – preemie tip with cover | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – preemie tip with cover | ||
10 | 00814247020604 | UM900 | ClearView Uterine Manipulator, 9cm | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView Uterine Manipulator | |
11 | 00814247020482 | UM202 | ClearView Uterine Manipulator, long tip | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView Uterine Manipulator | |
12 | 00814247020475 | UM201 | ClearView Uterine Manipulator, regular tip | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView Uterine Manipulator | |
13 | 00814247021090 | VPBB150113100 | BoogieBaby nasal aspirator – olive tip 3.25 inch long | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – olive tip 3.25 inch long | ||
14 | 00814247020857 | ROM-6025 | ROM Plus Cassette/Collection Kit | NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | 1 | ROM Plus, Quality Control for Fetal Membranes Rupture Tes | |
15 | 00814247020451 | ROM-QC | ROM Plus®, Quality Control for Fetal Membranes Rupture Test | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | ROM Plus® Quality Control Kit | |
16 | 00814247020284 | KDT-1000 | Koala Toco® Single-Use Tocodyamometer | HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | 2 | Koala Toco® | |
17 | 00814247020017 | UM700 | ClearView Uterine Manipulator, 7cm | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView Uterine Manipulator | |
18 | 00814247020666 | VAC-6000S | Kiwi® Vacuum Delivery System ProCup® | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® ProCup® | |
19 | 00814247021106 | VPBB150114100 | BoogieBaby nasal aspirator – olive tip 4.5 inch with cover | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – olive tip 4.5 inch with cover | ||
20 | 00814247020802 | PRS-EVAL | Traxi Panniculus Retractor with Retentus Technology | CCX | Support, Patient Position | traxi® Panniculus Retractor | ||
21 | 00814247020345 | PRS-1030 | Traxi Panniculus Retractor with Retentus Technology (BMI 30-50) | CCX | Support, Patient Position | 1 | traxi® Panniculus Retractor | |
22 | 00814247020659 | VAC-6000MTE | Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® OmniCup® | |
23 | 00814247020642 | VAC-6000MT | Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® OmniCup® | |
24 | 00814247020635 | VAC-6000ME | Kiwi® Vacuum Delivery System, OmniCup® | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® OmniCup® | |
25 | 00814247020628 | VAC-6000C | Kiwi® Vacuum Delivery System, Omni-C Cup® for Cesarean Section | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® Omni-C Cup® | |
26 | 00814247020611 | UM950 | ClearView Total Uterine Manipulator, 9cm tip | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView Total Uterine Manipulator | |
27 | 00814247020499 | UM750 | ClearView Total Uterine Manipulator, regular tip (7cm) | LKF | Cannula, Manipulator/Injector, Uterine | ClearView Total Uterine Manipulator | ||
28 | 00814247020710 | VPBB15013100 | BoogieBaby nasal aspirator – standard tip | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – standard tip | ||
29 | 00814247020437 | ROM-5025 | ROM Plus® Complete Kit Fetal Membranes Rupture Test | NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | 1 | ROM Plus®, Fetal Membranes Rupture Test | |
30 | 00814247020420 | ROM-5000 | ROM Plus® Complete Test Kit | NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | 1 | ROM Plus®, Fetal Membranes Rupture Test | |
31 | 00814247020406 | ROM-1025 | ROM Plus® Easy Strip Complete Kit Fetal Membranes Rupture Test | NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | ROM Plus®, Fetal Membranes Rupture Test | ||
32 | 00814247020093 | CIRC-1350 | AccuCirc® Circumcision Device | HFX | Clamp, Circumcision | 2 | AccuCirc® | |
33 | 00814247020079 | CIRC-1300 | AccuCirc® Circumcision Device | HFX | Clamp, Circumcision | 2 | AccuCirc® | |
34 | 00814247020055 | CIRC-1150 | AccuCirc® Circumcision Device | HFX | Clamp, Circumcision | 2 | AccuCirc® | |
35 | 00814247020031 | CIRC-1100 | AccuCirc® Circumcision Device | HFX | Clamp, Circumcision | AccuCirc® | ||
36 | 00814247020000 | VAC-6000M | Kiwi® Vacuum Delivery System, OmniCup® | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® OmniCup® | |
37 | 00814247020369 | PRS-1050 | Traxi Extender (BMI>50 - used with PH-25) | CCX | Support, Patient Position | 1 | traxi® Panniculus Retractor Extender | |
38 | 00814247020277 | IPC-5090 | Cables to IUP catheters: Edan F6 | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
39 | 00814247020260 | IPC-5080 | Cables to IUP catheters: Philips Avalon | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
40 | 00814247020253 | IPC-5061 | Cables to IUP catheters | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
41 | 00814247020246 | IPC-5060 | Cables to IUP catheters: Neoventa | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
42 | 00814247020239 | IPC-5050 | Cables to IUP catheters: Space Labs Medical 94000 | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
43 | 00814247020222 | IPC-5018 | Cables to IUP catheters: HP8040A 40mV | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
44 | 00814247020215 | IPC-5016 | Cables to IUP catheters: Litton Air-Shields Fetascan 1400 | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
45 | 00814247020208 | IPC-5014 | Cables to IUP catheters: GE Coro 115/116/118 | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
46 | 00814247020192 | IPC-5012 | Cables to IUP catheters: HP8040A 5mV/1350 | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
47 | 30814247020360 | PRS-0550 | Traxi Extender with Retentus Technology (BMI>50 - used with PH-25) | CCX | Support, Patient Position | traxi® Panniculus Retractor Extender | ||
48 | 00814247020598 | SBT-7019 | Cables to FSE | HGP | Electrode, Circular (Spiral), Scalp And Applicator | 2 | FSE Cables | |
49 | 00814247020581 | SBT-7018 | Cables to FSE | HGP | Electrode, Circular (Spiral), Scalp And Applicator | 2 | FSE Cables | |
50 | 00814247020574 | SBT-7017 | Cables to FSE | HGP | Electrode, Circular (Spiral), Scalp And Applicator | 2 | FSE Cables |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 10888277675698 | MPH6560 | MPH6560 | CONTROL, HARMONY HI LO | Medline | MEDLINE INDUSTRIES, INC. |
2 | 10859952006014 | A40400 | Di Description | Brand name | LIFE TECHNOLOGIES CORPORATION | |
3 | 10856626006172 | 997-61001 | 997-61001 | In-Vitro Diagnostic Use | uTASWako AFP-L3 Control L | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
4 | 10856626006134 | 995-61301 | 995-61301 | In-Vitro Diagnostic Use | uTASWako DCP Control L | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
5 | 10856626006073 | 993-61101 | 993-61101 | In-Vitro Diagnostic Use | uTASWako AFP-L3 Control H | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
6 | 10856626006066 | 991-61401 | 991-61401 | In-Vitro Diagnostic Use | uTASWako DCP Control H | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
7 | 10816467020348 | FastPack® IP SHBG 60 Immunoassay | 25000080 | 60 Test SHBG Immunoassay Complete Kit w/Calibrator and Control | FastPack® IP SHBG | QUALIGEN INC. |
8 | 10763924550507 | MD550 | Lipid and Glucose Measuring System | LipidPlus® Meter | JANT PHARMACAL CORPORATION | |
9 | 10758750030163 | 6842957 | 6842957 | VITROS Chemistry Products HCY 2 Performance Verifier I, II, III | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
10 | 10758750009053 | 1420025 | 1420025 | VITROS Immunodiagnostic Products Metabolism Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
11 | 10758750006953 | 6801747 | 6801747 | VITROS Chemistry Products mALB Performance Verifier II | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
12 | 10758750006946 | 6801746 | 6801746 | VITROS Chemistry Products mALB Performance Verifier I | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
13 | 10758750006243 | 6802894 | 6802894 | VITROS Immunodiagnostic Products Intact PTH Range Verifier | VITROS | ORTHO CLINICAL DIAGNOSTICS |
14 | 10758750006236 | 6802895 | 6802895 | VITROS Immunodiagnostic Products Intact PTH Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
15 | 10758750002573 | 6802313 | 6802313 | VITROS Chemistry Products AAT/HPT Performance Verifier III | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
16 | 10758750002566 | 6802312 | 6802312 | VITROS Chemistry Products AAT/HPT Performance Verifier II | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
17 | 10758750002559 | 6802311 | 6802311 | VITROS Chemistry Products AAT/HPT Performance Verifier I | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
18 | 10758750002528 | 6802303 | 6802303 | VITROS Immunodiagnostic Products Troponin I ES Range Verifiers | VITROS | ORTHO CLINICAL DIAGNOSTICS |
19 | 10758750002368 | 6802242 | 6802242 | VITROS Immunodiagnostic Products CA 19-9™ Range Verifiers | VITROS | ORTHO CLINICAL DIAGNOSTICS |
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21 | 10758750002085 | 6802158 | 6802158 | VITROS Immunodiagnostic Products NT-proBNP Range Verifiers | VITROS | ORTHO CLINICAL DIAGNOSTICS |
22 | 10758750001972 | 6802093 | 6802093 | VITROS Immunodiagnostic Products Anti-HBs Quantitative Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
23 | 10758750001545 | 6801863 | 6801863 | VITROS Immunodiagnostic Products Anti-HIV 1 + 2 Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
24 | 10758750001385 | 6801770 | 6801770 | VITROS Chemistry Products ApoB Performance Verifier I | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
25 | 10758750001378 | 6801769 | 6801769 | VITROS Chemistry Products ApoA1 Performance Verifier I | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
26 | 10758750001293 | 6801463 | 6801463 | VITROS Immunodiagnostic Products Anti-HAV Total Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
27 | 10758750001231 | 6801430 | 6801430 | VITROS Immunodiagnostic Products Anti-HBc Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
28 | 10758750001200 | 6801427 | 6801427 | VITROS Immunodiagnostic Products Anti-HBc IgM Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
29 | 10758750001156 | 6801421 | 6801421 | VITROS Immunodiagnostic Products Anti-HCV Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
30 | 10758750001033 | 6801044 | 6801044 | VITROS Immunodiagnostic Products Myoglobin Range Verifiers | VITROS | ORTHO CLINICAL DIAGNOSTICS |
31 | 10758750001002 | 6800880 | 6800880 | VITROS Immunodiagnostic Products CA 125 II™ Range Verifiers | VITROS | ORTHO CLINICAL DIAGNOSTICS |
32 | 10758750000999 | 6800879 | 6800879 | VITROS Immunodiagnostic Products CA 15-3™ Range Verifiers | VITROS | ORTHO CLINICAL DIAGNOSTICS |
33 | 10758750000982 | 6800878 | 6800878 | VITROS Immunodiagnostic Products AFP Range Verifiers | VITROS | ORTHO CLINICAL DIAGNOSTICS |
34 | 10758750000975 | 6800877 | 6800877 | VITROS Immunodiagnostic Products CEA Ranger Verifiers | VITROS | ORTHO CLINICAL DIAGNOSTICS |
35 | 10758750000968 | 6800876 | 6800876 | VITROS Immunodiagnostic Products PSA Range Verifiers | VITROS | ORTHO CLINICAL DIAGNOSTICS |
36 | 10758750000951 | 6800874 | 6800874 | VITROS Immunodiagnostic Products Cortisol Range Verifiers | VITROS | ORTHO CLINICAL DIAGNOSTICS |
37 | 10758750000944 | 6800873 | 6800873 | VITROS Immunodiagnostic Products Folate Range Verifiers | VITROS | ORTHO CLINICAL DIAGNOSTICS |
38 | 10758750000937 | 6800872 | 6800872 | VITROS Immunodiagnostic Products B12 Range Verifiers | VITROS | ORTHO CLINICAL DIAGNOSTICS |
39 | 10758750000906 | 6800845 | 6800845 | VITROS Immunodiagnostic Products NTx Range Verifiers | VITROS | ORTHO CLINICAL DIAGNOSTICS |
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41 | 10758750000845 | 6800661 | 6800661 | VITROS Immunodiagnostic Products Testosterone Range Verifiers | VITROS | ORTHO CLINICAL DIAGNOSTICS |
42 | 10758750000838 | 6800660 | 6800660 | VITROS Immunodiagnostic Products Testosterone Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
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46 | 10758750000784 | 6800375 | 6800375 | VITROS Immunodiagnostic Products Progesterone Range Verifiers | VITROS | ORTHO CLINICAL DIAGNOSTICS |
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