Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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B-P KNEE TIBIA PLATFORM COMPONENT, W/O BIOCOAT, W/ULTRACOAT, TYPE 0, SIZE 2 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
ENDOTEC, INC.
04-32-0462
Not in Commercial Distribution

  • 00814193021519 ()

  • SIZE 2, TYPE 0
04-32-0462

  • Cruciate-retaining total knee prosthesis
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 Medical USA LLC
43-5570-002-14
In Commercial Distribution

  • 00860003118313 ()


  • Medical networking interface unit
reSET-O® Mobile Application running on Android. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Introductory Access Limited Version provides limited access to the reSET-O product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution

  • 10851580008187 ()


  • Mental health/function therapeutic software, screen-viewed
reSET-O® Mobile Application running on iOS. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Introductory Access Limited Version provides limited access to the reSET-O product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution

  • 10851580008170 ()


  • Mental health/function therapeutic software, screen-viewed
reSET® Mobile Application running on Android. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Introductory Access Limited Version provides limited access to the reSET product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution

  • 10851580008156 ()


  • Mental health/function therapeutic software, screen-viewed
reSET® Mobile Application running on iOS. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Introductory Access Limited Version provides limited access to the reSET product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution

  • 10851580008149 ()


  • Mental health/function therapeutic software, screen-viewed
The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution

  • 08806094940763 ()


  • Self-care monitoring/reporting software
The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution

  • 08806094940756 ()


  • Self-care monitoring/reporting software
The ECG Monitor App intended for adults 22 years and older analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The IHRN feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification. The ECG Monitor App is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for users with known arrhythmias other than AFib or users under 22 years old. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
Samsung Electronics Co., Ltd.
1.3
In Commercial Distribution

  • 08806094948240 ()


  • Self-care monitoring/reporting software
The ECG Monitor App intended for adults 22 years and older analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The IHRN feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification. The ECG Monitor App is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for users with known arrhythmias other than AFib or users under 22 years old. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
Samsung Electronics Co., Ltd.
1.3
In Commercial Distribution

  • 08806094948233 ()


  • Self-care monitoring/reporting software
The ZEISS® Connect App mobile application will be an optional accessory of ZEISS® UNO 3 microscope product. ZEISS® Connect application SW will be available to the end user as an iOS app and user should be able to download and install the same from Apple App store. ZEISS® Connect App will pair wirelessly to the UNO3 variants of microscope and associated peripheral devices (like monitor etc.). This database entry covers UDI for SW version 2.0 and higher. Version 2.0-> UDI - (01)04049539070135(10)200-> Version 3.0-> UDI - (01)04049539070135(10)301 ->Version 4.2-> UDI - (01)04049539070135(10)420
Carl Zeiss Meditec AG
2.0
In Commercial Distribution

  • 04049539070135 ()


  • Multidisciplinary medical image management software
LAP-Instrument, Ø10mm, l=450mm, detach. Grasping forceps TENACULUM, d/a Stainl.steel handle, insul., w/o ratchethttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
DANNORITZER Medizintechnik GmbH & Co. KG
LMC-148-345
Not in Commercial Distribution

  • 04251351105326 ()
LMC-148-345

  • Rigid endoscopic tissue manipulation forceps, reusable
OtoNova Pro system for ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and ABR Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-A
In Commercial Distribution

  • 05060396173127 ()


  • Evoked-potential audiometer
OtoNova Pro system for DPOAE hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DP Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-D
In Commercial Distribution

  • 05060396173110 ()


  • Otoacoustic emission system, battery-powered
OtoNova Pro system for TEOAE hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and TE Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-T
In Commercial Distribution

  • 05060396173103 ()


  • Otoacoustic emission system, battery-powered
Package for 6-month subscription of Natural Cycles. Includes a Basal Body Thermometer and a subscription code for 6 months access to the app.
Naturalcycles Nordic AB
13
In Commercial Distribution

  • 07350014630131 ()


  • Self-care monitoring/reporting software
The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump. The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates electronic reports intended for a healthcare provider. The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies. The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity. The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
v2.X
Not in Commercial Distribution

  • B553202058OTC0 ()


  • Self-care monitoring/reporting software
The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump. The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates electronic reports intended for a healthcare provider. The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies. The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity. The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
v2.X
Not in Commercial Distribution

  • B553202057OTC0 ()


  • Self-care monitoring/reporting software
No Description
CHURCH & DWIGHT CO., INC.
00022600019558
In Commercial Distribution

  • 00022600019558 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Traxi Panniculus Retractor with Retentus Technology (BMI 30-50)
CLINICAL INNOVATIONS, LLC
PRS-0530
In Commercial Distribution

  • 30814247020346 ()
  • 40814247020343 ()


  • Abdominal retractor, hand-held
The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump. The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates electronic reports intended for a healthcare provider. The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies. The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity. The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
3.X
Not in Commercial Distribution

  • B553202258OTC0 ()


  • Self-care monitoring/reporting software
The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump. The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates electronic reports intended for a healthcare provider. The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies. The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity. The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
3.X
Not in Commercial Distribution

  • B553202257OTC0 ()


  • Self-care monitoring/reporting software
OtoNova Pro system for Clinical OAE hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-CLN-DA
In Commercial Distribution

  • 05060396173721 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
OtoNova Pro system for Clinical OAE hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-CLN-D
In Commercial Distribution

  • 05060396173714 ()


  • Otoacoustic emission system, battery-powered
OtoNova Pro system for Clinical OAE hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-CLN-DT
In Commercial Distribution

  • 05060396173486 ()


  • Otoacoustic emission system, battery-powered
Parky App is a symptom tracker mobile app for Parkinson’s Disease patients. It collects motion data through Apple Watch continuously and quantifies tremor and dyskinesia episodes based on clinically validated MM4PD algorithm. Tracked symptoms are reported as daily, weekly and monthly. Each report is shared with the prescribing healthcare professional through email.
H2O BILISIM YAZILIM ELEKTRONIK SAGLIK HIZMETLERI SANAYI VE TICARET LIMITED SIRKETI
V1
In Commercial Distribution

  • 00860009869707 ()


  • Tremor transducer
Kinesia Web Application/Portal 2 Software
Great Lakes Neurotechnologies Inc.
360-2011, Kinesia Web App/Portal 2
In Commercial Distribution

  • 00859584006164 ()


  • Tremor transducer
OtoNova Pro system for Clinical OAE and ABR hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-CLN-DTA
In Commercial Distribution

  • 05060396173172 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
OtoNova Pro system for DPOAE and ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DP+ABR Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-DA
In Commercial Distribution

  • 05060396173158 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
OtoNova Pro system for TEOAE and ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and TE+ABR Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-TA
In Commercial Distribution

  • 05060396173141 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
OtoNova Pro system for DPOAE and TEOAE hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DP+TE Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-DT
In Commercial Distribution

  • 05060396173134 ()


  • Otoacoustic emission system, battery-powered
EEG-based Neurofeedback Headset for use with the Axon mobile App, enabling users to modulate and redirect brain activity towards frequencies associated with relaxation and calm focused attention.
EXSURGO LIMITED
100500
In Commercial Distribution

  • 09413000095982 ()
100500

  • Psychophysiological biofeedback system
OtoNova Pro system for TEOAE, DPOAE and ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DPTE+ABR Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-DTA
In Commercial Distribution

  • 05060396173165 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 18", 1 temperature probe, 2 CO2 canisters 2.5lb/each, Bluetooth module to communicate with an App
FROSTIME LLC
V 1.0
In Commercial Distribution

  • 00860003258415 ()


  • Laboratory refrigerator/freezer
Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 13", 1 temperature probe, 2 CO2 canisters 1lb/each, Bluetooth module to communicate with an App
FROSTIME LLC
V 1.0
In Commercial Distribution

  • 00860003258408 ()


  • Laboratory refrigerator/freezer
Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.
Persona Medical
Evok 1600 Wireless
In Commercial Distribution

  • 00851362008070 ()


  • Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with RxEars APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.
Persona Medical
RxEars RX8
In Commercial Distribution

  • 00851362008056 ()


  • Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with RxEars APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.
Persona Medical
RxEars RX7
In Commercial Distribution

  • 00851362008018 ()


  • Air-conduction hearing aid, behind-the-ear
ARYS pro is intended to track and organize patient health and activity information recorded by sensors on the paretic and healthy wrist and using a mobile app for visualization.
tyromotion GmbH
3
In Commercial Distribution

  • 09120077180120 ()


  • Biomechanical function analysis/rehabilitation software
The Eko Core Electronic Stethoscope is a complete electronic stethoscope with digital & analog capabilities that wirelessly pairs to the free Eko Mobile App for recording, visualization, sharing, and annotation of sounds.
Eko Devices, Inc.
Model E4
In Commercial Distribution

  • 00863609000303 ()


  • Electronic acoustic stethoscope
The Eko Core Electronic Stethoscope is a complete electronic stethoscope with digital & analog capabilities that wirelessly pairs to the free Eko Mobile App for recording, visualization, sharing, and annotation of sounds.
Eko Devices, Inc.
E6
In Commercial Distribution

  • 00850010298016 ()


  • Electronic acoustic stethoscope
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-12-9308
In Commercial Distribution

  • 09348215045753 ()
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#

  • Non-constrained polyethylene acetabular liner
25x2pcs
VISGENEER, INC.
30G I
In Commercial Distribution

  • 04712558762342 ()
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#

  • Blood lancet, single-use
No Description
Stockert GmbH
S7032
Not in Commercial Distribution

  • 04260166370621 ()
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#

  • Percutaneous radio-frequency ablation system generator
Extra-Wide, Adjustable Height Armboard (SWISS)
SCHUERCH CORPORATION
800-0017-SWISS
In Commercial Distribution

  • 00810057373046 ()
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#

  • Arm procedure positioner, reusable
Calibra® Esthetic Resin Cement Veneer Kit
DENTSPLY INTERNATIONAL INC.
607200
Not in Commercial Distribution

  • D0026072001 ()

  • Weight: 2 Gram
  • 5 Syringes Cement, 5 Syringes Try-In Paste, 1 Bottle Adhesive, 1 Dispensing Well, 50 Tips, 1 Light Protection Cover, 1 Syringe Silane Coupling Agent, 1 Syringe Tooth Cond Gel, 25 App Needles
  • Weight: 1.8 Gram
607200

  • Dental composite resin
Scale, Digital Home Health Model DHH-10BT 440lb (200kg) x0.2lb (0.1kg) 300mm (L) x 360mm (W) x 8mm (H) includes (2) AAA batteries, tempered glass Includes Bluetooth connectivity compatible with Apple Health and Google Health APP
Rice Lake Weighing Systems, Inc.
DHH-10BT
In Commercial Distribution

  • 00850042373255 ()
201125

  • Stand-on floor scale, electronic
Suji device for BFR training. Suji comprises of a BLE enable pump, compression bands and a mobile app. The compression bands are worn at the top of the limb to restrict blood flow during exercise.
SECONDPERSPECTIVE LTD.
V2MDR-01
In Commercial Distribution

  • 05070000320403 ()


  • Tourniquet cuff, reusable
Wesper Lab (“the device”) is a digital recording device designed to collect sleep data in adult patients as prescribed by a healthcare professional. Wesper Lab uses a set of rechargeable, multi-use, adhesive patches that record physiological parameters during sleep. The kit is coupled with a charging pad for recharging, and a pulse oximeter to collect information about pulse rate and oxygen desaturations. The device employs a mobile application (“the app”), which resides on the patient’s personal mobile device, relaying sleep data wirelessly to a secure remote storage location (“the cloud”) for subsequent analysis by a healthcare professional. The app has 3 Bluetooth Low-Energy (BLE) ports, each of which receives multiple physiological channels from the patient. The device’s BLE ports connect to the following: 1. Abdominal patch 2. Thoracic patch 3. Pulse oximeter Data from the patches are transmitted via BLE throughout the night to the app, which uploads the data to the cloud. The third BLE port on the app connects to an authorized FDA-cleared pulse oximeter.
Tatch Inc.
WSWW-RE-K-N-V01-GRD
In Commercial Distribution

  • 00860007837012 ()


  • Polysomnograph
The Huma platform is a modular Software as a Medical Device (SaMD) which may utilise compatible devices and software to obtain data collated via a mobile app or web app and delivered to the clinician via a web portal or web app where it may be viewed to drive clinical management. It is intended to be used for the physiological and non-physiological intermittent or spot-check monitoring of all condition patients in professional healthcare facilities, such as clinics, hospitals or skilled nursing facilities, or in the patient’s home setting. It is intended for the monitoring of patients by trained healthcare professionals. The Huma platform comprises a number of different modules and functionalities that can be selected by the customer for configuration of care plans which can be further personalised for the patients. Clinical information collected from these modules is displayed on a clinician web portal and patient app with the addition of flagging out of range datasets, trend visualisation, goal setting and communication channels between clinicians and patients.
MedoPad Inc.
1.34
In Commercial Distribution

  • G2871002 ()
1002

  • Self-care monitoring/reporting software
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