Other products from "M DIALYSIS INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 07332699000256 250 x Microvial P000001 GWM Device, Monitoring, Intracranial Pressure 2 Microvials 250/pkg
2 07332699000324 5 x Reagent, 5 x Buffer P000063 PPM General Purpose Reagent 1 Pyruvate reagent
3 07332699000300 Reagent P000011 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Gluc Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate, Pyruvate and Glycerol. PPM General Purpose Reagent 1 Reagent Kit
4 07332699000058 106 8001788 FCP Box, Battery, Pocket 1 Battery 2x3V, 106 MD Pump
5 07332699000317 5 x Reagent, 5 x Buffer P000024 PPM General Purpose Reagent 1 Lactate reagent
6 07332699000928 100/10 P000050 Microdialysis catheter (20 kDa cut-off, 100 mm shaft length, 10 mm membrane leng Microdialysis catheter (20 kDa cut-off, 100 mm shaft length, 10 mm membrane length) for short term brain insertion using a tunnelation technique. GWM Device, Monitoring, Intracranial Pressure 2 70 Brain Microdialysis Catheter 100/10, 4/pkg
7 07332699000911 60/10 P000049 Microdialysis catheter (20 kDa cut-off, 60 mm shaft length, 10 mm membrane lengt Microdialysis catheter (20 kDa cut-off, 60 mm shaft length, 10 mm membrane length) for short term brain insertion using a tunnelation technique. GWM Device, Monitoring, Intracranial Pressure 2 70 Brain Microdialysis Catheter 60/10, 4/pkg
8 07332699000737 5 x Low, 5 x Elevated 8010306 GWM Device, Monitoring, Intracranial Pressure 2 Control Samples US
9 07332699000294 5 x Reagent, 5 x Buffer P000025 PPM General Purpose Reagent 1 Glycerol reagent
10 07332699000287 5 x Reagent, 5 x Buffer P000064 PPM General Purpose Reagent 1 Glutamate reagent
11 07332699001062 CNS 8003791 GWM Device, Monitoring, Intracranial Pressure 2 MD Pump Kit, Brain Tissue
12 07332699000652 5 x Reagent, 5 x Buffer P000023 PPM General Purpose Reagent 1 Glucose reagent
13 07332699000263 CNS P000151 GWM Device, Monitoring, Intracranial Pressure Perfusion fluid CNS
14 07332699000621 Reagent 8010361 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Gluc Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate and Pyruvate. PPM General Purpose Reagent 1 L-P-G Reagent kit
15 07332699000607 Clinical 8003295 Microdialysis analyzer using substance specific reagents to evaluate the concent Microdialysis analyzer using substance specific reagents to evaluate the concentrations in the samples given by the Microdialysis sampling system (Catheter, 106 MD Pump and Microvials). GWM Device, Monitoring, Intracranial Pressure 2 ISCUSflex
16 07332699000379 Rinsing Fluid 8002171 GWM Device, Monitoring, Intracranial Pressure Rinsing Fluid 0.5 L 8/pkg
17 07332699000348 Reagent 8002164 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Gluc Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate, Pyruvate, Glycerol and Glutamate mounted in a cassette. PPM General Purpose Reagent 1 Reagent Set B
18 07332699000973 130/10 P000131 Microdialysis catheter (20 kDa cut-off, 130 mm shaft length, 10 mm membrane leng Microdialysis catheter (20 kDa cut-off, 130 mm shaft length, 10 mm membrane length) for short term brain insertion using a bolt. GWM Device, Monitoring, Intracranial Pressure 2 70 Microdialysis Bolt Catheter 130/10, 4/pkg
19 07332699000355 Reagent 8002165 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Gluc Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate and Pyruvate mounted in a cassette. PPM General Purpose Reagent 1 Reagent Set C
20 07332699000034 106 P000003 Microdialysis pump running at a fixed flow rate of 0.3 µL/min for optimal Microd Microdialysis pump running at a fixed flow rate of 0.3 µL/min for optimal Microdialysis sampling. The pump is prepared with the Battery (07332699000058) and the 106 Syringe (07332699000072) filled with the Perfusion Fluid (07332699000263) and finally connected to the Microdialysis catheter.The 106 Microdialysis Pump is easy to operate. An initial flush is performed automatically. Flushes can be initiated manually if necessary. GWM Device, Monitoring, Intracranial Pressure 106 Microdialysis Pump
21 07332699000249 Rack P000028 GWM Device, Monitoring, Intracranial Pressure Microvial rack 12/pkg
22 07332699000072 106 8010191 GWM Device, Monitoring, Intracranial Pressure 106 Syringe
23 07332699000645 Sterile P000154 GWM Device, Monitoring, Intracranial Pressure Microvials in rack, Sterile 12x4
24 07332699000461 Calibrator P000057 Calibrator for ISCUSflex Microdialysis Analyzer. Contains calibrator levels for Calibrator for ISCUSflex Microdialysis Analyzer. Contains calibrator levels for Glucose, Lactate, Pyruvate, Glycerol and Glutamate. JIS Calibrator, Primary Calibrator A
25 07332699000331 Reagent 8002163 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Gluc Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate, Pyruvate and Glycerol mounted in a cassette. PPM General Purpose Reagent 1 Reagent Set A
Other products with the same Product Code "OUG"
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