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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

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.

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.

Thermidas VistaClinic Analyzer is a software app for the analysis of images that have been captured with Thermidas IRT-384 Tablet. The tools include adjustment of color scale, use of regions of interest, zoom & pan, and annotations.

LEGGINGS MAMAN 70 OPAQUE, SIZE M, MOKA, GRADUATED COMPRESSION 12/15 mmHg OPAQUE LEGGINGS FOR EXPECTANT MOhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#THERS WITH A POUCH AND A SUPPORTING BAND SUITABLE FOR THE GROWING BELLY

TPH®3 Easy-Twist Syringe Introductory Kit

Cylindrical Implant - 3.75 X Length 11.5mm Regular 2.42 Internal Hex

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth." https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth." https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#

Esthet-X® HD High Definition Micro Matrix Restorative Total-Etch Direct Restorative Kit

FluoroCore® 2+ Dual Cure Core Build-Up Material + Fast Endodontic Post Cement Introductory Kit

Handheld (Bluetooth Low Energy protocol) personal wireless microphone to help hear companions easier in noisy or challenging listening environments. Used with RX8 Hearing aid(s) and controlled with RxEars APP as well as controls on the unit itself.

Handheld (Bluetooth Low Energy protocol) personal wireless microphone to help hear companions easier in noisy or challenging listening environments. Used with Evok 1600 Hearing aid(s) and controlled with Persona APP as well as controls on the unit itself.

Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.

Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.

Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.

Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.

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 multi-use, adhesive patches that record physiological parameters during sleep. The kit is coupled with 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. This Device Identification is for a kit that is shipped without a charger.

The INVU by Nuvo™ System is a safe, non-invasive wearable monitoring system that provides continuous passive monitoring of vital pregnancy data of the pregnant person and the fetus through the INVU™ App. The information it provides is: Fetal heart rate (FHR), Maternal heart rate (MHR), and Uterine Activity (UA). The INVU by Nuvo™ System (as a part of the INVU 3200 Family/Catalogue) includes a wearable sensory band NV-BTSH-3000 (INVU Sensor Band™) that connects wirelessly to the INVU™ App installed on the pregnant person’s mobile device. The system may include additional peripheral devices, such as a blood pressure measuring device, depending on the care plan prescribed by the pregnant person’s medical supervisor. The INVU™ App installed on the pregnant person’s smartphone can log the measured blood pressure. The monitored pregnancy data is displayed on the mobile device by the INVU™ App. The recorded monitored pregnancy data can also be viewed by an assigned medical supervisor (or by a remote monitoring medical service), using the INVU Pro™ web application.

Hearing Device incorporating wireless protocol to be controlled with RxEars Pro APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.

Hearing Device (RIC) incorporating wireless protocol to be controlled with RxEars Pro APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.

Hearing Device (RIC) incorporating wireless protocol to be controlled with RxEars Pro APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.

Hearing Device incorporating wireless protocol to be controlled with RxEars Pro APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.

Urinary prosthesis, female, non-surgical

ENHANCED ALGORITHM ECG EVENT RECORDER

106900 Connex Server Application Software – Includes 2 thumb drives, one Production, one Test, with included software app, installer and Proview – Includes one ADT <(>&<)> one ORU production license, one ADT <(>&<)> one ORU test license – Includes 5 connectivity device test licenses – Includes Connex CS 1.8x DFU

Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT ONE Meter; Lancing Device; 10 MICROLET® Colored Lancets (provided sterile); User Guide (including CONTOUR DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card.

The Eko Core Attachment connects to (and digitizes) the analog stethoscope you already own. It attaches to almost all single-tubed stethoscopes including LittmannTM, Welch AllynTM, MDFTM, and ADCTM. The Eko Core Attachment wirelessly pairs to the free Eko mobile app for recording, visualization, sharing, and annotation of sounds.

The Eko Core Attachment connects to (and digitizes) the analog stethoscope you already own. It attaches to almost all single-tubed stethoscopes including LittmannTM, Welch AllynTM, MDFTM, and ADCTM. The Eko Core Attachment wirelessly pairs to the free Eko mobile app for recording, visualization, sharing, and annotation of sounds.

iSyncWaveTM is a wireless EEG measurement device that applies dry EEG measurement technology to an international 10-20 system compliant size-adjustable headset. iSyncWaveTM measures 19 channel EEG in real time and transfers the data through BLE wireless connection to the iSyncWaveTM App. The data is displayed and recorded via the iSyncWaveTM App. iSyncWaveTM uses dry electrode technology, which doesn’t require a preparation process(e.g., applying conductive gel), to obtain high quality EEG signals. Before measuring the EEG, you can check the impedance of each electrode under the impedance check screen in the iSyncWaveTM app. An EEG amplifier, analog-to-digital converter and Bluetooth are built in the device. All EEG signal is sampled at 250 Hz and then converted to digital data at 24-bit resolution. This device measures overall EEG data using 19 EEG electrodes, 1 Reference cable and 1 ground electrode. The measured data can be digitally converted to common average, longitudinal and transverse montage. The measured data is automatically uploaded to a secure cloud server via Wi-Fi connection and saved securely. The data saved in the cloud server can be seen on the iSyncWaveTM app. iSyncWaveTM can be only used by professional and/or medical personnel with product training and experience in EEG measurement. The professional and/or medical personnel can check the signal quality in real time and refer to the measured data in clinical practice.

Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT ONE Meter; Lancing Device; 10 MICROLET® Colored Lancets (provided sterile); User Guide (including CONTOUR DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card; CONTOUR® NEXT Control Solution.

TouchChat Express is a speech generating device with a 9.7 inch screen. Introducing TouchChat Express, a new communication device from Saltillo. TouchChat Express combines the popular TouchChat app with the iPad or iPad mini and the ChatWrap case. Add to that industry leading service, support and training and you have the complete package.

TouchChat Express is a speech generating device with a 9.7 inch screen. Introducing TouchChat Express, a new communication device from Saltillo. TouchChat Express combines the popular TouchChat app with the iPad or iPad mini and the ChatWrap case. Add to that industry leading service, support and training and you have the complete package

The Vertigenius™ system is intended to assist in the delivery and tracking of a prescribed exercise regime for Vestibular and Balance Rehabilitation. The Vertigenius™ system comprises a sensor that is worn behind the ear that detects head movement, a companion smart phone app and clinician platform. Vestibular rehabilitation exercises are prescribed by clinicians for their patient using the Vertigenius™ application platform. Vertigenius™ can be used with or without the head sensor. The companion app delivers the prescribed exercise regime, provides auditory and visual cues, tracks symptoms and monitors adherence. The head sensor is worn whilst the patient is carrying out specific prescribed head movement exercises for Vestibular and Balance Rehabilitation. It is used to provide real-time feedback to the patient so that they can see if they are carrying out the prescribed exercises correctly. The sensor and connected app provide feedback via the clinician platform to the prescribing clinician on the quality of exercise performance, changes in symptoms and adherence of the patient to the prescribed exercises, enabling the clinician to remotely monitor progress.

The Vertigenius™ system is intended to assist in the delivery and tracking of a prescribed exercise regime for Vestibular and Balance Rehabilitation. The Vertigenius™ system comprises a sensor that is worn behind the ear that detects head movement, a companion smart phone app and clinician platform. Vestibular rehabilitation exercises are prescribed by clinicians for their patient using the Vertigenius™ application platform. Vertigenius™ can be used with or without the head sensor. The companion app delivers the prescribed exercise regime, provides auditory and visual cues, tracks symptoms and monitors adherence. The head sensor is worn whilst the patient is carrying out specific prescribed head movement exercises for Vestibular and Balance Rehabilitation. It is used to provide real-time feedback to the patient so that they can see if they are carrying out the prescribed exercises correctly. The sensor and connected app provide feedback via the clinician platform to the prescribing clinician on the quality of exercise performance, changes in symptoms and adherence of the patient to the prescribed exercises, enabling the clinician to remotely monitor progress.

The Vertigenius™ system is intended to assist in the delivery and tracking of a prescribed exercise regime for Vestibular and Balance Rehabilitation. The Vertigenius™ system comprises a sensor that is worn behind the ear that detects head movement, a companion smart phone app and clinician platform. Vestibular rehabilitation exercises are prescribed by clinicians for their patient using the Vertigenius™ application platform. Vertigenius™ can be used with or without the head sensor. The companion app delivers the prescribed exercise regime, provides auditory and visual cues, tracks symptoms and monitors adherence. The head sensor is worn whilst the patient is carrying out specific prescribed head movement exercises for Vestibular and Balance Rehabilitation. It is used to provide real-time feedback to the patient so that they can see if they are carrying out the prescribed exercises correctly. The sensor and connected app provide feedback via the clinician platform to the prescribing clinician on the quality of exercise performance, changes in symptoms and adherence of the patient to the prescribed exercises, enabling the clinician to remotely monitor progress.

Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT ONE Meter; 20 CONTOUR® NEXT Blood Glucose Test Strips; Lancing Device; 20 MICROLET® Colored Lancets (provided sterile); User Guide (including CONTOUR DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card.

Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems.

Handsfree (Bluetooth) use of hearing aids with TV or other devices with AUX output. Also, can be used as a remote microphone to help hear companions easier in noisy or challenging listening environments. Used with Sombra XR, VR, XS, VS & X9 models. Hearing aid(s) and controlled with Persona APP as well as controls on the unit itself.

MyndStep is a wearable foot drop device, which comprises by stimulator unit, MyndStep APP, electrode lead wire, electrodes and leg brace. It can control the timing and duration of the stimulation by tracing the angle during walking. It uses FES (functional electrical stimulation) to treat and improve the patient's foot drop to help the patient improve their walking ability.