| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00840241600047 | 80014-001 | 80014-001 | The ASSURE Wearable Cardioverter Defibrillator System | MVK | Wearable Automated External Defibrillator | 3 | ASSURE WCD System |
| 2 | 00840241600160 | 80016-005 | 80016-005 | The Style B, Size 5, ASSURE Garment is a fabric top that contains Sensors that t The Style B, Size 5, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style B, Size 5 |
| 3 | 00840241600153 | 80016-004 | 80016-004 | The Style B, Size 4, ASSURE Garment is a fabric top that contains Sensors that t The Style B, Size 4, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style B, Size 4 |
| 4 | 00840241600108 | 80015-006 | 80015-006 | The Style A, Size 6, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 6, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style A, Size 6 |
| 5 | 00840241600061 | 80015-002 | 80015-002 | The Style A, Size 2, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 2, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style A, Size 2 |
| 6 | 00840241600184 | 80016-007 | 80016-007 | The Style B, Size 7, ASSURE Garment is a fabric top that contains Sensors that t The Style B, Size 7, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style B, Size 7 |
| 7 | 00840241600177 | 80016-006 | 80016-006 | The Style B, Size 6, ASSURE Garment is a fabric top that contains Sensors that t The Style B, Size 6, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style B, Size 6 |
| 8 | 00840241600146 | 80016-003 | 80016-003 | The Style B, Size 3, ASSURE Garment is a fabric top that contains Sensors that t The Style B, Size 3, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style B, Size 3 |
| 9 | 00840241600054 | 80015-001 | 80015-001 | The Style A, Size 1, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 1, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style A, Size 1 |
| 10 | 00840241600269 | 80433-002 | 80433-002 | CareStation Server acquires and displays data from the WCD for clinicians to view. | OUG | Medical Device Data System | 1 | CareStation Server |
| 11 | 00840241600191 | 80041-001 | 80041-001 | An electronic device used to program the ASSURE system and assist in patient fit An electronic device used to program the ASSURE system and assist in patient fitting and training | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Tablet |
| 12 | 00840241600122 | 80016-001 | 80016-001 | The Style B, Size 1, ASSURE Garment is a fabric top that contains Sensors that t The Style B, Size 1, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style B, Size 1 |
| 13 | 00840241600023 | 80004-003 | 80004-003 | Provides the connection between the Garment and the Monitor | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Therapy Cable |
| 14 | 00840241600207 | 3326502-003 | 3326502-003 | A portable case that holds the Monitor while wearing the ASSURE system | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Carry Pack |
| 15 | 00840241600139 | 80016-002 | 80016-002 | The Style B, Size 2, ASSURE Garment is a fabric top that contains Sensors that t The Style B, Size 2, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style B, Size 2 |
| 16 | 00840241600092 | 80015-005 | 80015-005 | The Style A, Size 5, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 5, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style A, Size 5 |
| 17 | 00840241600085 | 80015-004 | 80015-004 | The Style A, Size 4, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 4, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style A, Size 4 |
| 18 | 00840241600252 | 80429-003 | 80429-003 | ASSURE patient app is a component of CareStation. | OUG | Medical Device Data System | 1 | ASSURE Patient Application |
| 19 | 00840241600016 | 3326633-004 | 3326633-004 | A separate device that charges the Battery | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Charger |
| 20 | 00840241600115 | 80015-007 | 80015-007 | The Style A, Size 7, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 7, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style A, Size 7 |
| 21 | 00840241600078 | 80015-003 | 80015-003 | The Style A, Size 3, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 3, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style A, Size 3 |
| 22 | 00840241600030 | 80008-003 | 80008-003 | A part of the ASSURE System that provides power and displays system status information | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Monitor |
| 23 | 00840241600009 | 3322882-005 | 3322882-005 | A rechargeable battery that powers the ASSURE System | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Battery |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | E314ZIMMERPSIOMS0 | Zimmer online management system | Zimmer online management system | Zimmer online management system | Zimmer | MATERIALISE NV |
| 2 | E314SURGICASETRANSFER0 | SurgiCase Transfer | SurgiCase Transfer | SurgiCase Transfer | SurgiCase Transfer | MATERIALISE NV |
| 3 | E314SURGICASEOOS0 | SurgiCase OOS | SurgiCase OOS | SurgiCase OOS | SurgiCase OOS | MATERIALISE NV |
| 4 | E314SURGICASEONLINE0 | SurgiCase Online | SurgiCase Online | SurgiCase Online | SurgiCase Online | MATERIALISE NV |
| 5 | E314SIGNATUREOMS0 | Signature online management system | Signature online management system | Signature online management system | Signature | MATERIALISE NV |
| 6 | E314PROPLANCMFONLINE0 | ProPlan CMF Online | ProPlan CMF Online | ProPlan CMF Online | ProPlan CMF | MATERIALISE NV |
| 7 | 00885556741641 | 72205191 | 72205191 | INTELLIO LINK WEREWOLF | INTEllIO LINK WEREWOLF | SMITH & NEPHEW, INC. |
| 8 | 00885556741634 | 72205190 | 72205190 | LINK DOUBLEFLO PUMP | LINK DOUBLEFLOW PUMP | SMITH & NEPHEW, INC. |
| 9 | 00885556741627 | 72205189 | 72205189 | INTELLIO LINK DYONICS POWER II | INTELLIO LINK Dyonics Power II | SMITH & NEPHEW, INC. |
| 10 | 00885554037616 | 72204606 | 72204606 | DYONICS PULSE SOFTWARE TOP LEVEL | DYONICS | SMITH & NEPHEW, INC. |
| 11 | 00884838085510 | 784016 | DynaLync Prostate | Invivo | INVIVO CORPORATION | |
| 12 | 00883873892114 | 11150 | 11150-000018 | PACKAGED - CODE MANAGEMENT MODULE, WI-FI | NA | PHYSIO-CONTROL, INC. |
| 13 | 00883873892107 | 11150 | 11150-000019 | PACKAGED - CODE MANAGEMENT MODULE, WI-FI AND CO2 | NA | PHYSIO-CONTROL, INC. |
| 14 | 00883873863589 | 21340 | 21340-000841 | LIFEPAK SDK COMPATIBLE WITH CODE-STAT V10.1 | Code-Stat Version 10.1 | PHYSIO-CONTROL, INC. |
| 15 | 00883873851913 | 60600 | 60600-000145 | SOFTWARE EXECUTABLE, LUCAS Report Generator | LUCAS Report Generator | PHYSIO-CONTROL, INC. |
| 16 | 00883873837788 | 21340 | 21340-000850 | SOFTWARE, CODE-STAT CASEVIEW SOFTWARE INSTALL | Caseview | PHYSIO-CONTROL, INC. |
| 17 | 00864058000319 | 1 | Dental Medical Device Data Systems (MDDS) | Dentrix Smart Image | REALCLOUD IMAGING, INC. | |
| 18 | 00863609000358 | 1.2.4 | Windows PC Application for use with Eko products. | Eko App Windows | EKO DEVICES, INC. | |
| 19 | 00863609000341 | 1.2.9 | Eko mobile app for Android platforms for use with Eko products. | Eko Mobile App Android | EKO DEVICES, INC. | |
| 20 | 00863609000334 | 3.1.1 | iOS mobile device software for use with Eko products. | Eko Mobile App iOS | EKO DEVICES, INC. | |
| 21 | 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 | |
| 22 | 00861700000369 | "B" cable for GMA2 | RYPLX03 | Cable to connect Polytel PWR-09-02 GMA2 to Bayer family glucose meters | Polytel | POLYMAP WIRELESS |
| 23 | 00861700000352 | "A" cable for GMA2 | RPLYX02 | Cable to be used with Polytel PWR-09-02 GMA2 to support Abbott glucose meters | Polytel | POLYMAP WIRELESS |
| 24 | 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 |
| 25 | 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 | |
| 26 | 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 | |
| 27 | 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 | |
| 28 | 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 | |
| 29 | 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 | |
| 30 | 00860008848918 | 1.0.0 | SVIS-ASCENDIP | Video Integration Control System | SKYTRON ASCEND IP | JAM-LABS CORP. |
| 31 | 00860008848901 | 1.0.0 | Video Integration Control System | ORION RACK | JAM-LABS CORP. | |
| 32 | 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. | |
| 33 | 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. | |
| 34 | 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 | |
| 35 | 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 | |
| 36 | 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 | |
| 37 | 00860004366249 | 4.4 (Golan) | physIQ Medical Device Data System User Interface | physIQ UI (pinpointIQ) | PHYSIQ, INC | |
| 38 | 00860004366232 | 4.4 (Golan) | physIQ Medical Device Data System User Interface | physIQ UI (accelerateIQ) | PHYSIQ, INC | |
| 39 | 00860004366225 | 3.2 (Deneb) | physIQ Medical Device Data System Cloud Platform | physIQ Cloud Platform | PHYSIQ, INC | |
| 40 | 00860004366218 | 3.4 (Edison) | physIQ Medical Device Data System Android App | physIQ Android App | PHYSIQ, INC | |
| 41 | 00860003118337 | 43-5570-003-14 | Dedicated Laptop PC, part of the OR Base Station System | OR Laptop | CANARY MEDICAL USA LLC | |
| 42 | 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 | |
| 43 | 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 | |
| 44 | 00856100006202 | 3.1 | Qumulate | VARIAN MEDICAL SYSTEMS, INC. | ||
| 45 | 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. | |
| 46 | 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 |
| 47 | 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 | |
| 48 | 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 | |
| 49 | 00850677007310 | 2.X | EHR-Gateway Print | HYLAND LLC | ||
| 50 | 00850677007303 | 2.X | Encounter Manager | Image Link Encounter Workflow | HYLAND LLC |