| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 10841522127069 | 96102 | 96102 | XHIBIT CENTRAL STATION,96102 | MSX,DSI,MHX,MLD | System, network and communication, physiological monitors,DETECTOR AND ALARM, AR System, network and communication, physiological monitors,DETECTOR AND ALARM, ARRHYTHMIA,MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),MONITOR, ST SEGMENT WITH ALARM | 2 | Xhibit |
| 2 | 10841522124587 | 90207, 90207A, 90217, 90227,TARSAN | N/A | UNIVERSAL CUFF COVER LARGE SIZE - BOX OF 50 | DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2 | ABP |
| 3 | 10841522124570 | 90207, 90207A, 90217, 90227, TARSAN | 706-0182-00 | UNIVERSAL CUFF COVER STANDARD SIZE - BOX OF 50 | DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2 | ABP |
| 4 | 10841522123177 | 90227 | 90227-1 | ABP ONTRAK MONITOR, MULTI-LINGUAL | DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2 | ABP |
| 5 | 10841522122996 | 96501 | 96501 | 96501,XHIBIT XC4 | MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | Xhibit |
| 6 | 10841522122460 | CD12USB | CD12M | CARDIODIRECT12M | DPS | Electrocardiograph | 2 | CD12 |
| 7 | 10841522122453 | CD12USB | CD12MI | CARDIODIRECT12MI | DPS | Electrocardiograph | 2 | CD12 |
| 8 | 10841522122446 | CD12USB | CD12SENTINEL | CARDIODIRECT12, FOR SENTINEL | DPS | Electrocardiograph | 2 | CD12 |
| 9 | 10841522122439 | CD12US | CD12S | CARDIODIRECT12S | DPS | Electrocardiograph | 2 | CD12 |
| 10 | 10841522108341 | 90217 | N/A | 90217/90217A Ultralite ABP Monitor, Ambulatory Blood Pressure | DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2 | ABP |
| 11 | 10841522107832 | 96102 | L-96102 | CENTRAL STATION,96102,LOANER | MLD,DSI,MHX,MSX | MONITOR, ST SEGMENT WITH ALARM,DETECTOR AND ALARM, ARRHYTHMIA,MONITOR, PHYSIOLOG MONITOR, ST SEGMENT WITH ALARM,DETECTOR AND ALARM, ARRHYTHMIA,MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS | 2 | Xhibit |
| 12 | 10841522107719 | 90227 | L-90227-1 | LOANER - ABP ONTRAK MONITOR, MULTI-LINGUAL | DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2 | ABP |
| 13 | 10841522107160 | 96102 | N/A | Central Station | DSI,MSX,MHX,MLD | DETECTOR AND ALARM, ARRHYTHMIA,SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MO DETECTOR AND ALARM, ARRHYTHMIA,SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS,MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),MONITOR, ST SEGMENT WITH ALARM | 2 | Xhibit |
| 14 | 10841522106453 | 92506 | N/A | Ambulatory Blood Pressure (ABP) Report Management System | DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2 | ABP |
| 15 | 10841522106446 | 92506 | N/A | Ambulatory Blood Pressure (ABP) Report Management System | DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2 | ABP |
| 16 | 10841522105074 | 90217 | N/A | Ambulatory Blood Pressure Monitor | DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2 | ABP |
| 17 | 10841522105067 | 90217 | N/A | ABP ULTRALITE MONITOR,MULTI-LINGUAL | DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2 | ABP |
| 18 | 10841522100536 | 96102 | 011-0241-01 | DISPLAY,22" CAPACITIVE TOUCH,BLACK,ANTI-GLARE | MSX,MHX | SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS,MONITOR, PHYSIOLOGICAL, SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS,MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | Xhibit |
| 19 | 10841522100345 | 96102 | 96102 | XHIBIT CENTRAL STATION,96102 | MHX,MLD,DSI,MSX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),MONITOR, ST MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),MONITOR, ST SEGMENT WITH ALARM,DETECTOR AND ALARM, ARRHYTHMIA,SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS | 2 | Xhibit |
| 20 | 30841522123041 | ARIA; SUPPLY | 23189-106-401 | KIT,HOOK-UP,CASE OF 20,ARIA | DSH | RECORDER, MAGNETIC TAPE, MEDICAL | 2 | SPACELABS HEALTHCARE |
| 21 | 30841522122860 | TAY | 50-0191 | HOOK UP KIT WITH SINGLE USE POUCH, CASE OF 20 | DSH | RECORDER, MAGNETIC TAPE, MEDICAL | 2 | SPACELABS HEALTHCARE |
| 22 | 10841522129551 | 98201 | 040-1766-00 | UPGRADE, SENTINEL 10.5 TO 11.5 OR HIGHER | DQK | Computer, diagnostic, programmable | 2 | Sentinel |
| 23 | 10841522129537 | 98000 | 98000SL | PATHFINDER SL ANALYSER | DQK | Computer, diagnostic, programmable | 2 | PATHFINDER |
| 24 | 10841522129414 | 98200 | 040-1725-01 | SENTINEL 11 RDT TEST SYSTEM | DQK | Computer, diagnostic, programmable | 2 | SENTINEL |
| 25 | 10841522129315 | 98200 | 040-1748-01 | SENTINEL 11 / PATHFINDER SL KIT FR | DQK | Computer, diagnostic, programmable | 2 | SENTINEL |
| 26 | 10841522129308 | 98200 | 040-1724-01 | SENTINEL 11 HL7 TEST SYSTEM | DQK | Computer, diagnostic, programmable | 2 | SENTINEL |
| 27 | 10841522129292 | 98200 | 040-1723-01 | SENTINEL 11 NETWORKED TEST SYSTEM | DQK | Computer, diagnostic, programmable | 2 | SENTINEL |
| 28 | 10841522129285 | 98200 | 040-1722-01 | SENTINEL 11 STANDALONE TEST SYSTEM | DQK | Computer, diagnostic, programmable | 2 | SENTINEL |
| 29 | 10841522129070 | SUPPLY | 714-0018-00 | NIBP,HOSE ASSY,ADULT,QUICK RELEASE | DXN | System, measurement, blood-pressure, non-invasive | 2 | SPACELABS HEALTHCARE |
| 30 | 10841522129063 | 91436 | 91436F | FLEXPORT INTERFACE, PB840 VENTILATOR | DQA | Oximeter | 2 | SPACELABS HEALTHCARE |
| 31 | 10841522128752 | Supply | 685-0037-00 | PRE-WIRED NEO ELECTRODES SET,DIN,SPU,3/ST,100/BX | DSI | DETECTOR AND ALARM, ARRHYTHMIA | SPACELABS HEALTHCARE | |
| 32 | 10841522127359 | 91518; 92518 | 015-0313-01 | SAMPLE LINE,AGENT,W/SAMPLING TEE,10',50/BX | CBR | ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.) | SPACELABS HEALTHCARE | |
| 33 | 10841522127342 | 91518; 92518 | 015-0312-01 | SAMPLE LINE,AGENT,W/SAMPLING TEE,7',50/BX | CBR | ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.) | SPACELABS HEALTHCARE | |
| 34 | 10841522127052 | 90478 | 040-1429-04 | KIT, MULTI-BAND, WO/PS, PLEN, ACT ANT,ADC | MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | Ultraview |
| 35 | 10841522126864 | 90227 | 90227-2 | ABP ONTRAK MONITOR, GERMAN | DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2 | SPACELABS HEALTHCARE |
| 36 | 10841522105463 | 90478 | MDTM, MV1, DL, ST, UHF | MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | Ultraview | |
| 37 | 10841522126857 | TARSAN | 90217A-2 | ABP ULTRALITE MONITOR, GERMAN | DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2 | SPACELABS HEALTHCARE |
| 38 | 10841522126833 | 91496 | 700-0906-01 | CABLE,SPO2,MASIMO SET,LNCS | DQA | Oximeter | 2 | SPACELABS HEALTHCARE |
| 39 | 10841522126826 | 91496 | 700-0792-00 | CABLE,SPO2,NELLCOR,OXIMAX | DQA | Oximeter | 2 | SPACELABS HEALTHCARE |
| 40 | 10841522126819 | SUPPLY | 700-0002-00 | CABLE ASSY,SPO2,NELLCOR DFN SENSORS | DQA | Oximeter | 2 | SPACELABS HEALTHCARE |
| 41 | 10841522126444 | 91517 | 704-0003-00 | ACSRY,ADAPTER,AIRWAY,NEO,REUSE | CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 2 | SPACELABS HEALTHCARE |
| 42 | 10841522126437 | 91517 | 704-0002-00 | ACSRY,ADAPTER,AIRWAY,ADULT,REUSE | CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 2 | SPACELABS HEALTHCARE |
| 43 | 10841522126420 | 91517 | 704-0028 | CO2 SAMPLE LINE W/MALE LUER W/NAFION | CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 2 | SPACELABS HEALTHCARE |
| 44 | 10841522126406 | 91517 | 704-0026 | CO2 AIRWAY ADAPTER W/NAFION, PED/INF | CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 2 | SPACELABS HEALTHCARE |
| 45 | 10841522126390 | 91517 | 704-0024 | CO2 AIRWAY ADAPTER W/NAFION, PED/ADL | CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 2 | SPACELABS HEALTHCARE |
| 46 | 10841522126376 | 91517 | 704-0023 | CO2 AIRWAY ADAPTER, PEDIATRIC/ADULT | CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 2 | SPACELABS HEALTHCARE |
| 47 | 10841522126369 | 91517 | 704-0022 | CO2 ORAL/NASAL CANNULA W/O2, PEDIATRIC | CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 2 | SPACELABS HEALTHCARE |
| 48 | 10841522126352 | 91517 | 704-0020 | CO2 ORAL/NASAL CANNULA W/O2, ADULT | CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 2 | SPACELABS HEALTHCARE |
| 49 | 10841522105456 | 90478 | MDTM,MV1,ST,UHF 602-608MHZ | MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | Ultraview | |
| 50 | 10841522126338 | 91517 | 704-0017 | CO2 ORAL/NASAL CANNULA, ADULT | CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 2 | SPACELABS HEALTHCARE |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00864058000319 | 1 | Dental Medical Device Data Systems (MDDS) | Dentrix Smart Image | REALCLOUD IMAGING, INC. | |
| 2 | 00863609000358 | 1.2.4 | Windows PC Application for use with Eko products. | Eko App Windows | EKO DEVICES, INC. | |
| 3 | 00863609000341 | 1.2.9 | Eko mobile app for Android platforms for use with Eko products. | Eko Mobile App Android | EKO DEVICES, INC. | |
| 4 | 00863609000334 | 3.1.1 | iOS mobile device software for use with Eko products. | Eko Mobile App iOS | EKO DEVICES, INC. | |
| 5 | 00861700000376 | GMA2-L | Glucose Meter Accessory for existing glucose meters from LifeScan, providing Bl Glucose Meter Accessory for existing glucose meters from LifeScan, providing Bluetooth 2.1 connectivity for telehealth applications. This is built on a PWR-09-02 device, which an also support other glucose meter families if appropriate cables are provided:"B" cable: Bayer Breeze2, Contour, Contour TS, Contour XT, Contour next EZ,"A" cable: Abbott FreeStyle Lite, FreeStyle Freedom Lite | Polytel | POLYMAP WIRELESS | |
| 6 | 00861700000369 | "B" cable for GMA2 | RYPLX03 | Cable to connect Polytel PWR-09-02 GMA2 to Bayer family glucose meters | Polytel | POLYMAP WIRELESS |
| 7 | 00861700000352 | "A" cable for GMA2 | RPLYX02 | Cable to be used with Polytel PWR-09-02 GMA2 to support Abbott glucose meters | Polytel | POLYMAP WIRELESS |
| 8 | 00861700000345 | "L" cable for GMA2 | RPLYX01 | This cable is used to connect the Polytel PWR-09-02 GMA2 unit to glucose meters This cable is used to connect the Polytel PWR-09-02 GMA2 unit to glucose meters from LifeScan | Polytel | POLYMAP WIRELESS |
| 9 | 00861700000338 | PWR-09-02 | Glucose meter accessory providing Bluetooth connectivity for existing glucose me Glucose meter accessory providing Bluetooth connectivity for existing glucose meters. Depending on which cable is provisioned, this device supports different existing glucose meters."L" cable: LifeScan OneTouch Ultra, Ultra2, UltraMini, UltraEasy, Select, Basic"B" cable: Bayer Breeze2, Contour, Contour TS, Contour XT, Contour next EZ, "A" cable: Abbott FreeStyle Lite, FreeStyle Freedom Lite | Polytel GMA2 | POLYMAP WIRELESS | |
| 10 | 00860008898036 | 1.1.7 | MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitor MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions. | MonitAir | MONITAIR LLC | |
| 11 | 00860008898029 | 1.1.6 | MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitor MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions. | MonitAir | MONITAIR LLC | |
| 12 | 00860008898012 | 1.1.5 | MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitor MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions. | MonitAir | MONITAIR LLC | |
| 13 | 00860008898005 | 1.1.4 | MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitor MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions. | MonitAir | MONITAIR LLC | |
| 14 | 00860008848918 | 1.0.0 | SVIS-ASCENDIP | Video Integration Control System | SKYTRON ASCEND IP | JAM-LABS CORP. |
| 15 | 00860008848901 | 1.0.0 | Video Integration Control System | ORION RACK | JAM-LABS CORP. | |
| 16 | 00860007104947 | 1 | TRAQinform Reports is a 100% software medical device data system that provides u TRAQinform Reports is a 100% software medical device data system that provides users with the means to select, render and modify layouts of static and interactive reports. TRAQinform Reports does not perform any image analysis or image processing of medical images. The device provides features to render available data components to formatted PDF, web pages, or text files. | TRAQinform Reports | AIQ GLOBAL, INC. | |
| 17 | 00860007104923 | 1 | The TRAQinform Preprocessor is a 100% software medical device data system that p The TRAQinform Preprocessor is a 100% software medical device data system that provides users with the means to filter, perform quality checks, organize, and convert images from DICOM into other file formats including but not limited to Nearly Raw Raster Data (NRRD) format. | TRAQinform Preprocessor | AIQ GLOBAL, INC. | |
| 18 | 00860006137021 | Dr. ICU | Real time patient data monitoring, secure clinical communications, monitor & ve Real time patient data monitoring, secure clinical communications, monitor & vent waveforms, alarms and notifications anywhere, anytime for clinicians | Ceiba | CEIBA HEALTHCARE TECHNOLOGIES LLC | |
| 19 | 00860006137014 | ECONNECT IoMT Box | Brand-independent integration with Ceiba eConnect APIs of medical devices (monit Brand-independent integration with Ceiba eConnect APIs of medical devices (monitors, respirators, pumps, blood gas) and hospital systems | Ceiba | CEIBA HEALTHCARE TECHNOLOGIES LLC | |
| 20 | 00860006137007 | eClinics | eClinics is a stand-alone software product used by professional care providers i eClinics is a stand-alone software product used by professional care providers in ICU and other critical care settings for the presentation, collection, management and storage of patient information | Ceiba | CEIBA HEALTHCARE TECHNOLOGIES LLC | |
| 21 | 00860004366249 | 4.4 (Golan) | physIQ Medical Device Data System User Interface | physIQ UI (pinpointIQ) | PHYSIQ, INC | |
| 22 | 00860004366232 | 4.4 (Golan) | physIQ Medical Device Data System User Interface | physIQ UI (accelerateIQ) | PHYSIQ, INC | |
| 23 | 00860004366225 | 3.2 (Deneb) | physIQ Medical Device Data System Cloud Platform | physIQ Cloud Platform | PHYSIQ, INC | |
| 24 | 00860004366218 | 3.4 (Edison) | physIQ Medical Device Data System Android App | physIQ Android App | PHYSIQ, INC | |
| 25 | 00860003118337 | 43-5570-003-14 | Dedicated Laptop PC, part of the OR Base Station System | OR Laptop | CANARY MEDICAL USA LLC | |
| 26 | 00860003118320 | 43-5570-001-14 | The CTE with CHIRP Base Station subsystem is a unit with embedded firmware that The CTE with CHIRP Base Station subsystem is a unit with embedded firmware that facilitate communication with the CTE implant to serve as a conduit for implant data transmission in the environments where it will be used. The Home Base Station subsystem is for use by the Patient. | Canary Home Base Station | CANARY MEDICAL USA LLC | |
| 27 | 00860003118313 | 43-5570-002-14 | The OR Base Station subsystem is intended to send and receive data to and from t The OR Base Station subsystem is intended to send and receive data to and from the CTE implant over a wireless communication interface. Data sent to the CTE implant from the OR Base Station activates the CTE implant on the day of surgery. | Canary OR Base Station / OR PC App / OR Registration | CANARY MEDICAL USA LLC | |
| 28 | 00856100006202 | 3.1 | Qumulate | VARIAN MEDICAL SYSTEMS, INC. | ||
| 29 | 00853048008022 | CentrePoint Data Hub | The CentrePoint Data Hub is a home-based communication gateway that securely tra The CentrePoint Data Hub is a home-based communication gateway that securely transmits data captured by ActiGraph activity monitors. | ActiGraph | ACTIGRAPH L.L.C. | |
| 30 | 00850677007419 | 5.2.X | CS.5.2 | PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medic PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including patient demographics, images, videos and HL7 messages. It also handles user accounts, security, client configuration, and the folow of data between modalities and destination DICOM systems. PACSgear Enterprise exclusively supports PACSgear client products such as EHR Gateway, Image Link, MDR Video Touch and Web Forms. PACSgear Enterprise Server is not labeled for diagnostic use. | PACSgear Enterprise Server | HYLAND LLC |
| 31 | 00850677007396 | 5.1.X | PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medic PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data includingpatient demographics, images, videos, and HL7 messages. It also handles user accounts, security, clientconfiguration, and the flow of data between modalities and destination DICOM systems. PACSgear | PACSgear Enterprise Server | HYLAND LLC | |
| 32 | 00850677007389 | 1.X | Image Link Plus supports imaging workflows that do not follow the radiology work Image Link Plus supports imaging workflows that do not follow the radiology workflow by providing a pseudo order message to the modality that contains patient and visit information from the Electronic Medical Record (EMR). | Image Link Plus | HYLAND LLC | |
| 33 | 00850677007310 | 2.X | EHR-Gateway Print | HYLAND LLC | ||
| 34 | 00850677007303 | 2.X | Encounter Manager | Image Link Encounter Workflow | HYLAND LLC | |
| 35 | 00850677007297 | 3.X | Image Link | HYLAND LLC | ||
| 36 | 00850677007273 | 4.X | Web Forms | ModLink Web Forms | HYLAND LLC | |
| 37 | 00850677007266 | 3.X | EHR-Gateway | HYLAND LLC | ||
| 38 | 00850677007259 | 5.X | Core Server | PACSgear Enterprise Server | HYLAND LLC | |
| 39 | 00850677007235 | 2.X | EHR Gateway | PACSgear EHR Gateway | HYLAND LLC | |
| 40 | 00850677007228 | 3.X | Web Forms, Mod Link Web Forms | PACSgear Web Forms | HYLAND LLC | |
| 41 | 00850677007211 | 3.X | Mod LInk | PACSgear Mod Link | HYLAND LLC | |
| 42 | 00850677007204 | 1.X | Image Link Encounter Workflow | PACSgear Image Link Encounter Workflow | HYLAND LLC | |
| 43 | 00850677007198 | 2.X | Image Link | PACSgear Image Link | HYLAND LLC | |
| 44 | 00850677007167 | 4.X | PACSgear Core Server | PACSgear Core Server | HYLAND LLC | |
| 45 | 00850040853025 | Mobile RPM - Enterprise | Health Harmony Mobile is a component of the Health Harmony Remote Patient Monito Health Harmony Mobile is a component of the Health Harmony Remote Patient Monitoring system. It is a software client application that runs on a personal mobile device, used by patients to easily communicate and exchange information with their healthcare provider. The Health Harmony Mobile application collects patient responses to health assessment questions and receives patient vital signs from Bluetooth-connected medical measuring devices. The Mobile application automatically and securely transmits patient information to the provider. The Health Harmony Mobile application can also display educational material and other messages received from the provider, such as reminders encouraging patients to complete a health session or to take medications as ordered. Patients can read messages and send replies to the clinician, and may also accept or a decline a video conference call initiated by their clinician, directly from the Health Harmony Mobile application. The Enterprise version of Health Harmony Mobile is pre-loaded by the manufacturer on a personal mobile device that is provided to the patient in a Health Harmony Kit. | Health Harmony | CARE INNOVATIONS, LLC | |
| 46 | 00850040853018 | Mobile RPM - BYOD | Health Harmony Mobile is a component of the Health Harmony Remote Patient Monito Health Harmony Mobile is a component of the Health Harmony Remote Patient Monitoring system. It is a software client application that runs on a personal mobile device, used by patients to easily communicate and exchange information with their healthcare provider. The Health Harmony Mobile application collects patient responses to health assessment questions and receives patient vital signs from Bluetooth-connected medical measuring devices. The Mobile application automatically and securely transmits patient information to the provider. The Health Harmony Mobile application can also display educational material and other messages received from the provider, such as reminders encouraging patients to complete a health session or to take medications as ordered. Patients can read messages and send replies to the clinician, and may also accept or a decline a video conference call initiated by their clinician, directly from the Health Harmony Mobile application. The BYOD version of Health Harmony Mobile is available for download by the patient onto their own personal mobile device. | Health Harmony | CARE INNOVATIONS, LLC | |
| 47 | 00850031821026 | Nile for HCPs | A digital epilepsy care management web portal for HCP. | Nile HCP | AI NILE INC | |
| 48 | 00850031821019 | Nile for Android | A digital epilepsy care management platform application for Android. | Nile | AI NILE INC | |
| 49 | 00850031821002 | Nile for iOS | A digital epilepsy care management platform application for iOS. | Nile | AI NILE INC | |
| 50 | 00850015699016 | 43-5570-006-14 | After the surgery is completed, the OR Barcode Scanner can be used to scan the b After the surgery is completed, the OR Barcode Scanner can be used to scan the barcodes on the labels of the CTE and other implanted TKA components. | OR Barcode Scanner | CANARY MEDICAL USA LLC |