| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 06944904099781 | DC-25 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | DC-25 | ||
| 2 | 06944904097954 | 115-049881-00 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | L11-3U Sensor Holder Package | ||
| 3 | 06944904099088 | DC-80 PRO | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | DC-80 PRO | ||
| 4 | 06944904099064 | 115-051014-00 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | UltraView Disk | ||
| 5 | 06944904098630 | 115-050194-00 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | USB three-button foot switch Kit | ||
| 6 | 06944904098500 | 115-044872-00 | KOI | Stimulator, Nerve, Peripheral, Electric | 2 | NMT Module (Package/no accessory) | ||
| 7 | 06944904089898 | 115-030623-00 | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | Wireless Footswitch | ||
| 8 | 06944904090061 | 115-042844-00 | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | pen probe cable package | ||
| 9 | 06944904098487 | 120-005596-00 | OIJ | Biopsy Needle Guide Kit | 2 | NGB-035 Needle-guided Bracket | ||
| 10 | 06944904086903 | 115-022518-00 | JGS | ELECTRODE, ION SPECIFIC, SODIUM | 2 | Drainage Unit | ||
| 11 | 06944904063171 | 115-030430-00 | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | BNC head ECG Lead(FDA ) | ||
| 12 | 06944904018676 | BS-200 | JGS | ELECTRODE, ION SPECIFIC, SODIUM | 2 | Auto Chemistry Analyzer BS-200 | ||
| 13 | 06944904089980 | 115-006988-00 | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | Trolley VCR-wire Package | ||
| 14 | 06944904098654 | 115-050190-00 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 3-Lead,ECG,Univ,Pinch,36",AAMI Kit | ||
| 15 | 06944904098647 | 115-050191-00 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | DC-IN CABLE（MIC）Kit | ||
| 16 | 06944904097947 | 120-005524-00 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | UMT-500Plus Mobile Cart | ||
| 17 | 06944904099071 | DC-80 EXP | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | DC-80 EXP | ||
| 18 | 06944904098531 | 115-050198-00 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | Wheeled Boarding Bag | ||
| 19 | 06944904098104 | 115-044346-00 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 4D Module Kit | ||
| 20 | 06944904097992 | 040-003528-00 | DRW | Adaptor, Lead Switching, Electrocardiograph | 2 | 12Pin 12-Lead Host Cable | ||
| 21 | 06944904096773 | 115-046900-00 | DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 2 | ScvO2 function upgrade kit | ||
| 22 | 06944904089706 | 115-010085-00 | IYN | System, imaging, pulsed doppler, ultrasonic | Rechargeable Li-ion Battery Pack | |||
| 23 | 06944904098470 | 115-050570-00 | MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 | IBP_CO_AG Module(with 02)(FDA)II | ||
| 24 | 06944904098371 | 115-051375-00 | MSX | System, Network And Communication, Physiological Monitors | 2 | 0155 Signal Converter Pack(LED Adapter) | ||
| 25 | 06944904098326 | M6 Exp | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | M6 Exp | ||
| 26 | 06944904097138 | Z108-08 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | P4-1c Phased Array Tranducer 84004-30 | ||
| 27 | 06944904097107 | 120-005534-00 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | L20-5s Ultrasonic Probe(SMS) | ||
| 28 | 06944904096759 | 115-046928-00 | CCJ | Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | 2 | ORIDION CO2(Package/no accessory) | ||
| 29 | 06944904092973 | 115-046285-00 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | Konica Table Mount | ||
| 30 | 06944904092942 | 120-004749-00 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | 7L4s Ultrasonic Probe Konica(FDA) | ||
| 31 | 06944904092829 | 120-004652-00 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | L16-4HU Ultrasonic Probe(FDA) | ||
| 32 | 06944904092775 | 120-004613-00 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | P10-4U Ultrasonic Probe(FDA) | ||
| 33 | 06944904092690 | z.one pro | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | z.one pro Diagnostic Ultrasound System | ||
| 34 | 06944904092614 | Z125-00 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | L20-5 Linear Array Tranducer 87222-00 | ||
| 35 | 06944904092553 | Z108-30 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | P4-1c Phased Array Tranducer 84004-30 | ||
| 36 | 06944904092515 | 120-004576-00 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | P8-3Ts Ultrasonic Probe(FDA) | ||
| 37 | 06944904091969 | 045-003255-00 | MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 | N12 roll stands(With iPM/iMEC adapter) | ||
| 38 | 06944904090603 | 040-002258-00 | KOI | Stimulator, Nerve, Peripheral, Electric | 2 | Bandage for NMT sensor | ||
| 39 | 06944904089850 | 115-003486-00 | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | IO Extend Module(FDA) | ||
| 40 | 06944904089621 | 115-023072-00 | IYN | System, imaging, pulsed doppler, ultrasonic | M9 Li-ion battery FRU(FDA) | |||
| 41 | 06944904089607 | 115-035885-00 | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | ECG Module | ||
| 42 | 06944904089430 | PR3A-30-90482 | ITX | Transducer, ultrasonic, diagnostic | 2 | XDUCER ENDOCAVITY,65EC10EB,FDA | ||
| 43 | 06944904089249 | PR1F-30-91138 | ITX | Transducer, ultrasonic, diagnostic | 2 | 3C1 Ultrasonic Transducer(FDA) | ||
| 44 | 06944904089096 | PL2J-30-90996 | ITX | Transducer, ultrasonic, diagnostic | 2 | 75LT38EA Ultrasonic Transducer(FDA) | ||
| 45 | 06944904089089 | PL2F-30-90823 | ITX | Transducer, ultrasonic, diagnostic | 2 | 65EL60EA Ultrasonic Transducer(FDA) | ||
| 46 | 06944904088921 | PL1J-30-90759 | ITX | Transducer, ultrasonic, diagnostic | 2 | 7L4A Ultrasonic Transducer(FDA) | ||
| 47 | 06944904088488 | 120-003623-00 | ITX | Transducer, ultrasonic, diagnostic | 2 | L10-3s Ultrasonic Probe(FDA) | ||
| 48 | 06944904088457 | 120-003605-00 | ITX | Transducer, ultrasonic, diagnostic | 2 | DE10-3U Ultrasonic Probe(FDA) | ||
| 49 | 06944904088280 | 120-003462-00 | ITX | Transducer, ultrasonic, diagnostic | 2 | SC5-1E Ultrasonic Probe(FDA) | ||
| 50 | 06944904087405 | 120-001112-01 | ITX | Transducer, ultrasonic, diagnostic | 2 | L14-6Ns Ultrasonic Transducer(FDA) |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 05060484630082 | PN1287 | The zensor monitoring device is a small, lightweight, wearable, non-invasive, re The zensor monitoring device is a small, lightweight, wearable, non-invasive, re-chargeable battery operated portable system connected to an electrode accessory (single-use disposable Intelesens zensor Electrode Array) which in turn is in contact with the patient’s body. The device is to be used in the patient’s home environment to provide clinicians with patient physiological data, while allowing for patient mobility. The zensor monitoring system provides full disclosure ECG and cardiac event monitoring for adult patients. The physiological parameters monitored include ECG and Respiration waveforms, Heart Rate and Respiration Rate, as well as lethal and high acuity arrhythmias (Asystole, Tachycardia, Ventricular Fibrillation, Bradycardia and Atrial Fibrillation). The zensor monitoring device has the option to store full disclosure ECG & Respiration data and/or wirelessly transmit pre-defined event alerts to the Intelesens zensoronline system for review by healthcare practitioners. All physiological data stored on the device can be downloaded for viewing on Intelesens zensor+ (Ambulatory ECG Full Disclosure ECG and Event Viewer) for later analysis by a clinician. | ZENSOR | INTELESENS LIMITED | |
| 2 | 05060484630051 | PN0811 | The zensor software system is a web and PC based tool assisting clinicians in ma The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The web and PC components of the software can be configured to be used individually or together.The zensor+ software allows review of all physiological data that has been previously stored and downloaded from the monitoring device for later analysis by a clinician.The system is intended to be used to obtain physiological readings for use in routine check-ups. Any events or variations in physiological readings are not intended to be used to summon emergency care. | Zensor+ software | INTELESENS LIMITED | |
| 3 | 05060484630044 | PN0810 | The zensor software system is a web and PC based tool assisting clinicians in ma The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The web and PC components of the software can be configured to be used individually or together.The zensoronline software has the option to receive wirelessly transmitted pre-defined event alerts from the Intelesens' monitoring device for review by healthcare practitioners and/or review all physiological data that has been previously stored and downloaded from the monitoring device for later analysis by a clinician.The system is intended to be used to obtain physiological readings for use in routine check-ups. Any events or variations in physiological readings are not intended to be used to summon emergency care. | Zensoronline software | INTELESENS LIMITED | |
| 4 | 05060484630006 | PN0620 | The zensor monitoring device is a small, lightweight, wearable, non-invasive, re The zensor monitoring device is a small, lightweight, wearable, non-invasive, re-chargeable battery operated portable system connected to an electrode accessory (single-use disposable Intelesens zensor Electrode Array) which in turn is in contact with the patient’s body. The device is to be used in the patient’s home environment to provide clinicians with patient physiological data, while allowing for patient mobility. The zensor monitoring system provides full disclosure ECG and cardiac event monitoring for adult patients. The physiological parameters monitored include ECG and Respiration waveforms, Heart Rate and Respiration Rate, as well as lethal and high acuity arrhythmias (Asystole, Tachycardia, Ventricular Fibrillation, Bradycardia and Atrial Fibrillation). The zensor monitoring device has the option to store full disclosure ECG & Respiration data and/or wirelessly transmit pre-defined event alerts to the Intelesens zensoronline system for review by healthcare practitioners. All physiological data stored on the device can be downloaded for viewing on Intelesens zensor+ (Ambulatory ECG Full Disclosure ECG and Event Viewer) for later analysis by a clinician. | ZENSOR | INTELESENS LIMITED | |
| 5 | 05060483830100 | EQ-EX-B4 | Equivital LifeMonitor | HIDALGO LIMITED | ||
| 6 | 05060483830094 | EQ-EX-B3 | Equivital LifeMonitor | HIDALGO LIMITED | ||
| 7 | 05060483830087 | EQ-02-B4 | Equivital LifeMonitor | HIDALGO LIMITED | ||
| 8 | 05060483830070 | EQ-02-B3 | Equivital LifeMonitor | HIDALGO LIMITED | ||
| 9 | 05060483830063 | EQ-EX-SEM-009 | Equivital LifeMonitor | HIDALGO LIMITED | ||
| 10 | 05060483830056 | EQ-02-SEM-012 | Equivital LifeMonitor | HIDALGO LIMITED | ||
| 11 | 05060483830049 | EQ-EX-B1-1 | Equivital LifeMonitor | HIDALGO LIMITED | ||
| 12 | 05060483830032 | EQ-02-B2-1 | Equivital LifeMonitor | HIDALGO LIMITED | ||
| 13 | 05060483830025 | EQ-02-B1-1 | Equivital LifeMonitor | HIDALGO LIMITED | ||
| 14 | 05060483830018 | EQ-EX-SEM-008 | Equivital LifeMonitor | HIDALGO LIMITED | ||
| 15 | 05060483830001 | EQ-02-SEM-007 | Equivital LifeMonitor | HIDALGO LIMITED | ||
| 16 | 05060472442932 | 00-1026-R | 867423 | Tempus Pro - Printer, SpO2, NIBP, ECG, ETCO2, Temp & IBP | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED |
| 17 | 05060472442925 | 00-1024-R | 867422 | Tempus Pro - Printer, SpO2, NIBP, ECG, ETCO2 & Temp | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED |
| 18 | 05060472442918 | 00-1007-R | 867421 | Tempus Pro Rainbow - with Capnometry & with BT Dock | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED |
| 19 | 05060472442901 | 00-1004-R | 867420 | Tempus Pro Rainbow - with Capnometry & without BT Dock | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED |
| 20 | 05060472441348 | 01-2508 | Corsium Crew Application | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | ||
| 21 | 05060472441331 | 01-2507 | Philips IntelliSpace Corsium | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | ||
| 22 | 05060472441256 | 01-2244 | Smart Mount | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | |
| 23 | 05060472441232 | 01-2182 | 12-Lead ECG Modular Cable (AAMI) 8ft | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | |
| 24 | 05060472441218 | 01-2179 | 6-Lead ECG Limb Leads for Modular Cable (AAMI) | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | |
| 25 | 05060472441195 | 01-2177 | 4-Lead ECG Modular Trunk Cable (AAMI) 8ft | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | |
| 26 | 05060472441140 | 01-2186 | Tempus Pro - Printer Paper with 110mm grid | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | |
| 27 | 05060472441133 | 01-2184 | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | ||
| 28 | 05060472441102 | 00-1036-R | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | ||
| 29 | 05060472441096 | 00-1034-R | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | ||
| 30 | 05060472441058 | 00-1026-R | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | ||
| 31 | 05060472441027 | 00-1024-R | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | ||
| 32 | 05060472440785 | 01-2243 | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | ||
| 33 | 05060472440761 | 01-2115 | Smiths LogiCal Transducer Adaptor Cable | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | |
| 34 | 05060472440754 | 01-2114 | Argon DTX Plus Transducer Adaptor Cable | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | |
| 35 | 05060472440747 | 01-2113 | Transpac & Art-Line Transducer Adaptor Cable | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | |
| 36 | 05060472440730 | 01-2111 | Edwards TruWave Transducer Adaptor Cable | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | |
| 37 | 05060472440723 | 01-2110 | Utah Deltran Transducer Adaptor Cable | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | |
| 38 | 05060472440716 | 01-2108 | 2-Channel Invasive Pressure Universal Cable | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | |
| 39 | 05060472440655 | 00-1007 | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | ||
| 40 | 05060472440648 | 00-1006 | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | ||
| 41 | 05060472440631 | 00-1005 | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | ||
| 42 | 05060472440624 | 00-1004 | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | ||
| 43 | 05060472440617 | 01-2112 | USB Serial Inline Converter Cable | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | |
| 44 | 05060472440419 | 01-2501 | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | ||
| 45 | 05060472440389 | 01-2053 | Tempus Pro Vehicle Adapter | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | |
| 46 | 05060472440310 | 01-1012 | Battery Charger | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | |
| 47 | 05060472440303 | 01-2049 | Mains Power Supply | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | |
| 48 | 05060472440297 | 01-2051 | Tempus Lithium-Ion Battery (Black) | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | |
| 49 | 05060472440280 | 01-2203 | Tempus Pro 3-Lead Neonatal ECG Cable (AAMI) 6ft | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED | |
| 50 | 05060472440235 | 01-2070 | Tempus Pro 12-Lead ECG Cable (AAMI) 8ft | Tempus Pro | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED |