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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
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
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
CALZIFICIO PINELLI SRL
057611
In Commercial Distribution
- 08300496057611 ()
048670
- Compression/pressure tubular garment
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.
TherMidas Oy
Thermidas VistaClinic Analyzer
In Commercial Distribution
- 06429810718044 ()
ThAnalyzer
- Infrared thermography system
TPH®3 Easy-Twist Syringe Introductory Kit
DENTSPLY INTERNATIONAL INC.
642706
Not in Commercial Distribution
- D0026427061 ()
- Weight: 3 Gram
- Total Volume: 3 Milliliter
- 8 TPH3 Syringes, 5 P&B Unit Doses, 1 Prisma Gloss Fine and Extrafine Syringe, 1 syringe Tooth Cond Gel, 1 shade guide, 25 polishing cups, 1 mandrel, Enhance Discs, Cups, & Points, 5 App Tips
642706
- Dental composite resin
Esthet-X® HD High Definition Micro Matrix Restorative Total-Etch Direct Restorative Kit
DENTSPLY INTERNATIONAL INC.
630607
Not in Commercial Distribution
- D0026306071 ()
- Weight: 0.25 Gram
- 6 Compules® Tips, 1 Compules® Tips Gun, 3 Compula® Tips, Enhance® Finishers, 6 Bond Unit Doses, 1 Unit Dose Holder, 6 Flocked Applicator Tips, 1 Syringe Tooth Cond Gel, 25 App Tips
- Total Volume: 3 Milliliter
630607
- Dental composite resin
FluoroCore® 2+ Dual Cure Core Build-Up Material + Fast Endodontic Post Cement Introductory Kit
DENTSPLY INTERNATIONAL INC.
612400
Not in Commercial Distribution
- D0026124001 ()
- Weight: 4.75 Gram
- 2 Tooth Colored Syringes, 2 Blue Syringes, 1 bottle each Xeno®, P&B, and activator, 25 Mixing Tips, 25 Intraoral Tips, 10 Endo Intaoral Tips, 1 Disp Well, 50 App Tips, 50 Root Canal Tips
612400
- Dental composite resin
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.
Persona Medical
Remote Microphone Wireless Streamer
In Commercial Distribution
- 00851362008063 ()
- Air-conduction hearing aid, behind-the-ear
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.
Persona Medical
Remote Microphone Wireless Streamer
In Commercial Distribution
- 00851362008131 ()
- Air-conduction hearing aid, behind-the-ear
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.
Persona Medical
Sombra XS
In Commercial Distribution
- 00851362008124 ()
- Air-conduction hearing aid, behind-the-ear