AccessGUDID - DEVICE: Health Harmony (00850040853025)

GUDID

Device Identifier (DI) Information

Brand Name: Health Harmony
Version or Model: Mobile RPM - Enterprise
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Care Innovations, LLC

Primary DI Number: 00850040853025
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 966632304 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64242	Vulnerable patient home-monitoring software, professional-only	A software program intended to allow healthcare professionals to remotely observe and assess the physical/mental state and environment of a vulnerable/geriatric patient (e.g., patient with dementia) whilst at home. It is intended for real-time analysis and recording of data from devices in the home (motion sensors, medical monitoring equipment) and uses algorithms to highlight patterns of concerning behaviour or physiological readings. The data is intended to be reviewed remotely by a healthcare professional so that appropriate actions can be coordinated (e.g., contact next of kin, call paramedic). It is not intended for diagnosis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUG	Medical Device Data System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 42306534-e31d-4f91-b1e1-48be7aebecb6
Public Version Date: April 12, 2024
Public Version Number: 2
DI Record Publish Date: October 17, 2022