| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 15060484630027 | PN1111 | The Intelesens Aingeal is used to monitor and transmit physiological data to a r The Intelesens Aingeal is used to monitor and transmit physiological data to a remote application for display or analysis by a clinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in an unmonitored or unobserved situation.This re-usable device is intend to be used on the patient for short term periods only.The device is intended to be used on adult patients for monitoring of ECG, respiration, heart rate, skin temperature and activity levels in a healthcare setting.The device can be used where information on ECG, respiration, heart rate, skin temperature, and activity levels would be useful.The device uses on-board ECG arrhythmia detection algorithms to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event. The device transmits the data to the remote application at user defined intervals or upon the detection of an arrhythmia event (arrhythmia or threshold breach). | MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 | Aingeal | |
| 2 | 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. | MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 | ZENSOR | |
| 3 | 05060484630037 | PN1120 | The Aingeal 3-Patch Electrode Array is an electrocardiograph (ECG), respiration The Aingeal 3-Patch Electrode Array is an electrocardiograph (ECG), respiration and temperature electrode. It is a disposable, pre-gelled, self-adhesive, single lead electrode array, which is designed to be used in contact with the patient’s skin. The device is used in conjunction with the Aingeal Device in order to monitor vital signs for ECG, respiration, motion and temperature for ambulatory and non-ambulatory patients in a hospital environment.This is a single use device and is intended to be used on an adult patient for a period of up to 72 hours before a replacement is required. | MLN | Electrode, Electrodcardiograph, Multi-Function | 2 | Aingeal 3-patch electrode | |
| 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. | MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 | ZENSOR | |
| 5 | 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. | MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 | Zensoronline software | |
| 6 | 05060484630099 | PN1360 | The zensor electrode array, electrocardiograph (ECG) and respiration electrode i The zensor electrode array, electrocardiograph (ECG) and respiration electrode is a disposable, pre-gelled, self-adhesive, three lead electrode array, which is in contact with the patient's skin. The device is used in conjunction with the zensor device in order to monitor vital signs for ECG, respiration and motion for ambulatory and non-ambulatory patients in a home environment. This is a single use device and is intended to be used on an adult patient for a period of up to 6 days before a replacement is required. | MLN | Electrode, Electrocardiograph, Multi-Function | 2 | Zensor electrode | |
| 7 | 05060484630013 | PN1088 | The zensor electrode array, electrocardiograph (ECG) and respiration electrode i The zensor electrode array, electrocardiograph (ECG) and respiration electrode is a disposable, pre-gelled, self-adhesive, three lead electrode array, which is in contact with the patient's skin. The device is used in conjunction with the zensor device in order to monitor vital signs for ECG, respiration and motion for ambulatory and non-ambulatory patients in a home environment. This is a single use device and is intended to be used on an adult patient for a period of up to 72 hours before a replacement is required. | MLN | Electrode, Electrocardiograph, Multi-Function | 2 | Zensor electrode |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00841983104336 | A-WSS-002-ZA | A-WSS-002-ZA | Wireless Surge Solution, field deployable ambulatory monitoring of up to 8 patie Wireless Surge Solution, field deployable ambulatory monitoring of up to 8 patients with pop-up central monitoring | NK-HealthProtect Wireless Surge Solution | NIHON KOHDEN AMERICA, INC. |
| 2 | 00841983104237 | A-WSS-001-ZA | A-WSS-001-ZA | Wireless Surge Solution, field deployable ambulatory monitoring of up to 8 patie Wireless Surge Solution, field deployable ambulatory monitoring of up to 8 patients with pop-up central monitoring | NK-HealthProtect Wireless Surge Solution | NIHON KOHDEN AMERICA, INC. |
| 3 | 00841983104190 | A-WSS-001-ZA | A-WSS-001-ZA | Emergency response system for field deployable ED overflow needs | Emergency Response System | NIHON KOHDEN AMERICA, INC. |
| 4 | 00841983104183 | RNS-6804-7460 | RNS-6804-7460 | No Audio Remote Network Station with Dell OptiPlex 7460 All-In-One Computer | NA | NIHON KOHDEN AMERICA, INC. |
| 5 | 00841983104176 | RNS-6803-7460 | RNS-6803-7460 | Remote Network Station with Dell OptiPlex 7460 All-In-One Computer | NA | NIHON KOHDEN AMERICA, INC. |
| 6 | 00841983104145 | YS-19003 | YS-19003 | DAU Breakaway Cable, 30M for Life Scope G9 | Life Scope G9 | NIHON KOHDEN AMERICA, INC. |
| 7 | 00841983104053 | A/EJ110-0010 CABLE | A/EJ110-0010 CABLE | AUDIO CABLE, 10', NK-ACU5112A | Life Scope G9 | NIHON KOHDEN AMERICA, INC. |
| 8 | 00841983104046 | A/326391 CABLE | A/326391 CABLE | G9 - 6' DB9 M/F RS-232 EXTENSION | Life Scope G9 | NIHON KOHDEN AMERICA, INC. |
| 9 | 00841983104039 | A/646225 CABLE | A/646225 CABLE | G9 - DVI VIDEO M/M | Life Scope G9 | NIHON KOHDEN AMERICA, INC. |
| 10 | 00841983104022 | A/CE620NK | A/CE620NK | ATEN, G9 KVM DVI & SERIAL OVER IP | Life Scope G9 | NIHON KOHDEN AMERICA, INC. |
| 11 | 00841983104015 | G9-KVM/ZA | G9-KVM/ZA | BRANCH CABLE EXT, G9, UP TO 300FT | Life Scope G9 | NIHON KOHDEN AMERICA, INC. |
| 12 | 00841983103896 | A/FQW-50-3-100 | A/FQW-50-3-100 | PAPER for BSM-2/4/5000+ CNS | NA | NIHON KOHDEN AMERICA, INC. |
| 13 | 00841983103889 | A/FQW-50-2-100 | A/FQW-50-2-100 | PAPER for BSM-6000 | NA | NIHON KOHDEN AMERICA, INC. |
| 14 | 00841983103872 | WS-371P | WS-371P | Recorder module for BSM-3500 | NA | NIHON KOHDEN CORPORATION |
| 15 | 00841983103865 | DH-350P | DH-350P | Handle for BSM-3500 | NA | NIHON KOHDEN CORPORATION |
| 16 | 00841983103544 | NK-ASAAPPLIANCE | NK-ASAAPPLIANCE | WLAN STATION, FOR BSM-2300 | NA | NIHON KOHDEN AMERICA, INC. |
| 17 | 00841983103537 | WS-971R | WS-971R | RNS STRIP RECORDER | NA | NIHON KOHDEN AMERICA, INC. |
| 18 | 00841983103520 | NK-CE770-CNS-S | NK-CE770-CNS-S | INTERACTIVE REMOTE CNS-6200 | NA | NIHON KOHDEN AMERICA, INC. |
| 19 | 00841983103513 | NK-CE770CNS-D | NK-CE770CNS-D | INTERACTIVE RMT - DUAL CNS | NA | NIHON KOHDEN AMERICA, INC. |
| 20 | 00841983103506 | NK-ASPECT-BISX | NK-ASPECT-BISX | ASPECT BISX OPTION, BSM6000 | BIS™ | NIHON KOHDEN AMERICA, INC. |
| 21 | 00841983103414 | QI-930P | QI-930P | DAU INTERFACE UNIT for BSM-9100A | NA | NIHON KOHDEN AMERICA, INC. |
| 22 | 00841983103407 | MU-971RA | MU-971RA | MAIN UNIT FOR CNS-9701A | NA | NIHON KOHDEN AMERICA, INC. |
| 23 | 00841983103391 | MU-910RA | MU-910RA | MAIN UNIT FOR BSM-9100A | NA | NIHON KOHDEN AMERICA, INC. |
| 24 | 00841983103193 | BSM-4114A | BSM-4114A | PATIENT MONITOR, without RECORDER | NA | NIHON KOHDEN AMERICA, INC. |
| 25 | 00841983103186 | BSM-4104A | BSM-4104A | PATIENT MONITOR, with RECORDER | NA | NIHON KOHDEN AMERICA, INC. |
| 26 | 00841983103179 | BSM-2301A | BSM-2301A | BEDSIDE MONITOR, PORTABLE | NA | NIHON KOHDEN AMERICA, INC. |
| 27 | 00841983103117 | QF-801P | QF-801P | Interface for Covidien Microstream Micropod | NA | NIHON KOHDEN AMERICA, INC. |
| 28 | 00841983103100 | QI-170P | QI-170P | Wireless LAN station | NA | NIHON KOHDEN AMERICA, INC. |
| 29 | 00841983103001 | BSM-3572 | BSM-3572A | Bedside Monitor, Low Acuity, NK SpO2 | Life Scope VS | NIHON KOHDEN AMERICA, INC. |
| 30 | 00841983102998 | BSM-3552 | BSM-3552A | Bedside Monitor, Low Acuity, Mellcor SpO2 | Life Scope VS | NIHON KOHDEN AMERICA, INC. |
| 31 | 00841983102981 | BSM-3532 | BSM-3532A | Bedside Monitor, Low Acuity, Masimo SpO2 | Life Scope VS | NIHON KOHDEN AMERICA, INC. |
| 32 | 00841983102967 | ZS-910PA | ZS-910PA | Transmitter, ECG and Resp, WEP-4208 | NA | NIHON KOHDEN AMERICA, INC. |
| 33 | 00841983102851 | YS-098P2 | YS-098P2 | Additional alarm indicator unit, cable length | NA | NIHON KOHDEN AMERICA, INC. |
| 34 | 00841983102844 | YS-098P1 | YS-098P1 | Additional alarm indicator unit, cable length | NA | NIHON KOHDEN AMERICA, INC. |
| 35 | 00841983102837 | YS-096P3 | YS-096P3 | Unit connection cable for connecting data acquisition unit | NA | NIHON KOHDEN AMERICA, INC. |
| 36 | 00841983102820 | YS-096P2 | YS-096P2 | Unit connection cable for connecting data acquisition unit | NA | NIHON KOHDEN AMERICA, INC. |
| 37 | 00841983102752 | TL-631T3 | TL-631T3 | Finger probe Adult, child (20 kg or more) Finger or toe | BluPRO® | NIHON KOHDEN AMERICA, INC. |
| 38 | 00841983102691 | TL-220T | TL-220T | Multi-site probe Adults, child (3 kg or more) | BluPRO® | NIHON KOHDEN AMERICA, INC. |
| 39 | 00841983102684 | TL-201T | TL-201T | Finger probe Adult, child (20kg or more) Finger | BluPRO® | NIHON KOHDEN AMERICA, INC. |
| 40 | 00841983102622 | TG-900P | TG-900P | CO2 Sensor Kit, Standard | NA | NIHON KOHDEN AMERICA, INC. |
| 41 | 00841983102578 | QF-909P | QF-909P | Interface for Connecting Merck & Co., Inc./MSD Neuromuscular Transmission Monitor | NA | NIHON KOHDEN AMERICA, INC. |
| 42 | 00841983102363 | BSM-1773 | BSM-1773A | Transport Monitor, NK SpO2 | Life Scope PT | NIHON KOHDEN AMERICA, INC. |
| 43 | 00841983102356 | BSM-1753 | BSM-1753A | Transport Monitor, Nellcor SpO2 | Life Scope PT | NIHON KOHDEN AMERICA, INC. |
| 44 | 00841983102349 | BSM-1733 | BSM-1733A | Transport Monitor, Masimo SpO2 | Life Scope PT | NIHON KOHDEN AMERICA, INC. |
| 45 | 00841983102288 | JT-950P | JT-950P | CO connection cord Bath probe and inline sensor methods | NA | NIHON KOHDEN AMERICA, INC. |
| 46 | 00841983102196 | YS-097P9 | YS-097P9 | VL cable set (Second), cable length | NA | NIHON KOHDEN AMERICA, INC. |
| 47 | 00841983102189 | YS-097P8 | YS-097P8 | VL cable set (Second), cable length | NA | NIHON KOHDEN AMERICA, INC. |
| 48 | 00841983102172 | YS-097P6 | YS-097P6 | VL cable set (Main), cable length | NA | NIHON KOHDEN AMERICA, INC. |
| 49 | 00841983102165 | YS-097P5 | YS-097P5 | VL cable set (Main), cable length | NA | NIHON KOHDEN AMERICA, INC. |
| 50 | 00841983102141 | QI-372P | QI-372P | Interface, 2 Multi-Link socket, RGB socket | NA | NIHON KOHDEN AMERICA, INC. |