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No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 09350855000054 N00091-NNA Chemical Indicator US SP-P18 (NNA VARIANT) JOJ Indicator, Physical/Chemical Sterilization Process 2 Trophon Chemical Indicator
2 09350855000047 N00091 Easy Reader CI US2 Gen2 SP-P16 (GE VARIANT) JOJ Indicator, Physical/Chemical Sterilization Process 2 Trophon Chemical Indicator
3 09350855000542 N05003 N05003 Chemical Indicator JOJ Indicator, Physical/Chemical Sterilization Process trophon Chemical Indicator
4 09350855000207 N05006 RFID Operator card OUG Medical Device Data System trophon AcuTrace Operator Card
5 09350855000177 N05003 Chemical Indicator JOJ Indicator, Physical/Chemical Sterilization Process trophon Chemical Indicator
6 09350855000030 N00037-NNA Sonex-HL Each unit AHECC 2847.00.00 (NNA VARIANT) OUJ High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers 2 Sonex-HL
7 09350855000023 N00037 Sonex-HL Each Unit AHECC 2847.00.00 (GE VARIANT) OUJ High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers Sonex-HL
8 09350855000559 N00099 N00099 Curved Probe Positioner OUJ High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist 2 trophon Curved Probe Positioner
9 09350855000184 N05000-1 High Level Disinfection System OUJ High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist trophon2
10 09350855000146 N05002 35% Hydrogen Peroxide Cartridge OUJ High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist trophon Sonex-HL
11 09350855000122 N00010-US-RFB Trophon US Refurbished OUJ High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers 2 Trophon EPR
12 09350855000016 N00010-NNA Trophon EPR Nth America AHECC 8419.20.00 (NNA VARIANT) OUJ High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers 2 Trophon EPR
13 09350855000009 N00010-US Trophon EPR USA Variant AHECC 8419.20.00 (GE VARIANT) OUJ High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers 2 Trophon EPR
14 09350855000290 N00102 FFF Cover, Biopsy Forceps Clean Ultrasound Probe Cover
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No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00191506004392 M004LSPRO400100 M004LSPRO400100 LABSYSTEM™ PRO EP Review Workstation Software LABSYSTEM™ PRO BOSTON SCIENTIFIC CORPORATION
2 00093815716136 71613 71613 Accessory Plug Type A & USB Cable Replacement Kit FreeStyle ABBOTT DIABETES CARE LTD
3 00093815708452 70845 70845 Abbott Diabetes Care USB Data Cable Software Abbott ABBOTT DIABETES CARE INC
4 00093815000839 70845 70845 Abbott Diabetes Care USB Data Cable Software Abbott ABBOTT DIABETES CARE INC
5 00021292013622 TRUE MANAGER AIR APP - Android TRUE MANAGER AIR APP - Android TRUE MANAGER AIR TRIVIDIA HEALTH, INC.
6 00021292013196 TRUE MANAGER AIR APP - Apple iOS TRUE MANAGER AIR APP - Apple iOS TRUE MANAGER AIR TRIVIDIA HEALTH, INC.
7 B595VMM2050 VMM2050 Mobile Application VMM2050 The Vios Monitoring System (VMS) Mobile Application is indicated for use by heal The Vios Monitoring System (VMS) Mobile Application is indicated for use by healthcare professionals for centralized monitoring of patient data within a healthcare facility. The Vios mobile application receives and displays patient physiological and waveform data and alarms generated by Vios’ proprietary patient vitals monitoring software. The Vios Mobile Application is intended for clinical professionals who are expected to have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients. Vios Monitoring System Mobile Application MURATA VIOS PRIVATE LIMITED
8 B595VCS2050 VCS2050 Software VCS2050 The Vios Monitoring System (VMS) Central Server (CS) Software acts as the server The Vios Monitoring System (VMS) Central Server (CS) Software acts as the server relay for the VMS system. It transmits, stores, and encrypts patient demographic and vitals data between multiple Vios BSMs to the Vios CSM. The Vios Central Server allows for retrieval of patient demographics, vitals and alarm data and product utilization through retrieval of audit logs. The Vios Central Server allows for creation and configuration of Monitoring Units (i.e. Wards), Caregivers, Departments, Rooms, Beds, and Default Monitoring Profiles for BSMs that are in Connected Mode.The Vios Central Station Monitor/Central Server Software is indicated for use by healthcare professionals for the purpose of centralized monitoring of patient data within a healthcare facility. The Vios Central Station Monitor/Central Server SW receives, stores, manages and displays patient physiological and waveform data and alarms generated by Vios proprietary patient vitals monitoring software. Vios Monitoring System Central Server MURATA VIOS PRIVATE LIMITED
9 B595CSM20500 CSM2050 Software CSM2050 The Vios Monitoring System (VMS) Central Station Monitor (CSM) Software is indic The Vios Monitoring System (VMS) Central Station Monitor (CSM) Software is indicated for use by healthcare professionals for centralized monitoring of patient data within a healthcare facility. The Vios CSM SW receives, stores, manages, and displays patient physiological and waveform data, and alarms generated by Vios proprietary patient vitals monitoring software. The Vios CSM SW is intended for clinical professionals who are expected to have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients. Vios Monitoring System Central Station Monitor MURATA VIOS PRIVATE LIMITED
10 B334DBX1P40 1.4 DBx MIRADA MEDICAL LIMITED
11 B236VUE3000 3.0 Sunquest VUE supports laboratories in the management of patient reports and to t Sunquest VUE supports laboratories in the management of patient reports and to transfer, store, and display test results and information. Sunquest VUE CLINISYS, INC
12 B236SMG6300 6.3 Sunquest Mitogen™ Genetics supports laboratories in the management of patient ge Sunquest Mitogen™ Genetics supports laboratories in the management of patient genetic testing data, support reporting that includes variant information, and to transfer, store, and display test results and information. Sunquest Mitogen Genetics CLINISYS, INC
13 B236IX3200 3.2 Sunquest Instrument Interfacing provides interfaces between laboratory instrumen Sunquest Instrument Interfacing provides interfaces between laboratory instruments and Sunquest products. Sunquest Instrument Interfacing CLINISYS, INC
14 B236AI5300 5.3 Sunquest Application Interface (AI) is to provide interfaces between client syst Sunquest Application Interface (AI) is to provide interfaces between client systems and Sunquest products to support laboratories in the management of laboratory workflow (order entry through reporting) and transfer test results and information Sunquest Application Interfacing CLINISYS, INC
15 60889978014576 CS WinOMS 8014573 WinOMS Practice Management Software CS WinOMS CARESTREAM HEALTH, INC.
16 58051887042642 THD HRStation 800299 THD HRStation is an integrated proctological station mainly dedicated to the dia THD HRStation is an integrated proctological station mainly dedicated to the diagnosis of pathologies of the anal canal and specifically to the diagnosis of precancerous lesions.Thanks to the THD Procto Software, it allows the proctologist to have a unique, modular and expandable diagnostic system that, in addition to the realization of high resolution anoscopy, can also allow further diagnostic investigations such as anorectal manometry and Transanal ultrasound. THD Procto Software System THD SPA
17 18033737712389 THD Proctostation 800198 THD Proctostation is an integrated, modular and expandable one-stop platform for THD Proctostation is an integrated, modular and expandable one-stop platform for the Colo-Rectal Surgeon/Proctologist, to perform Anorectal manometry, EAUS and High Resolution Anoscopy. It includes:- THD Procto Software - proctology integrated software- Dedicated hardware composed of an All in One professional Personal Compuiter - Insulation Transformer - Procto Trolley with pivoting wheels, brakes and orientable dringging handle THD Procto Software System THD SPA
18 18033737712341 THD 4K CAM 800195 THD 4K CAM is a very-high-resolution video camera, which allows shooting up to 4 THD 4K CAM is a very-high-resolution video camera, which allows shooting up to 4K resolution using THD's diagnostic and surgical devices, equipped with a special mechanical connection interface and septic protection sleeve.Capture is done using the THD ProctoSoftware interface, a software suite that allows for the recording of clinical data such as patient records, examination, anorectal canal images, anorectal canal ultrasound images, and anorectal pressure values (anorectal manometry) when used with appropriate medical devices including the purchased video camera. THD Procto Software System THD SPA
19 15694311111153 NOX-BTUNI_A 544012 Nox W7 Link Kit - A NOX MEDICAL EHF.
20 15694311110637 NOX-BTUNI_R 544011 Nox W7 Link Kit - R NOX MEDICAL EHF.
21 15694311110620 NOX-BTUNI_S 544010 Nox W7 Link Kit - S NOX MEDICAL EHF.
22 15099590733926 V4.42 DVD, LabPro V4.42 Panel Update-09 (US); LabPro V4.42 Panel Update-09 DVD Kit (US DVD, LabPro V4.42 Panel Update-09 (US); LabPro V4.42 Panel Update-09 DVD Kit (US); LabPro V4.42 System Kit w/Panel Update-09 (US) MicroScan BECKMAN COULTER, INC.
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28 15099590676896 V2.0 LabPro-MBT System MicroScan BECKMAN COULTER, INC.
29 15099590676889 V4.42 LabPro Connect Data Management System MicroScan BECKMAN COULTER, INC.
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31 15019517225495 22-4095-0206-25 PharmGuard SMITHS MEDICAL ASD, INC.
32 15019517225488 22-0117-0203-25 PharmGuard SMITHS MEDICAL ASD, INC.
33 10884521795150 VDASHSUBEXS01 Ventilation Dashboard v1.0 Excess Use Subscription Vital Sync COVIDIEN LP
34 10884521795143 VDASHSUB01 Ventilation Dashboard v1.0 Subscription Vital Sync COVIDIEN LP
35 10884521706675 SBTWR v1.0 Spontaneous Breathing Trial and Weaning Readiness Application v1.0 Vital Sync COVIDIEN LP
36 10884521706668 EWS v1.0 Early Warning Score Application v1.0 Vital Sync COVIDIEN LP
37 10841522125003 96190 1.X.X XPREZZNET,96190 Xprezznet SPACELABS HEALTHCARE (WASHINGTON), INC
38 10841522123658 92848 5.x.x ENTERPRISE NETWORK INTERFACE,92848 Intesys Clinical Suite SPACELABS HEALTHCARE (WASHINGTON), INC
39 10841522123641 92843 5.x.x HL7 VITAL SIGNS INTERFACE,92843 Intesys Clinical Suite SPACELABS HEALTHCARE (WASHINGTON), INC
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43 10841522104558 94267 Sentinel SPACELABS HEALTHCARE (WASHINGTON), INC
44 10841522104541 94267 XPREZZON and qube Display Options Spacelabs Healthcare SPACELABS HEALTHCARE (WASHINGTON), INC
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