Health Harmony

GUDID 00850040853025

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.

Care Innovations, LLC

Vulnerable patient home-monitoring software, professional-only

• Primary Device ID: 00850040853025
• NIH Device Record Key: 42306534-e31d-4f91-b1e1-48be7aebecb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health Harmony
• Version Model Number: Mobile RPM - Enterprise
• Company DUNS: 966632304
• Company Name: Care Innovations, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850040853025 [Primary]

FDA Product Code

• OUG: Medical Device Data System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-25
• Device Publish Date: 2022-10-17

On-Brand Devices [Health Harmony]

• 00850040853056: A Health Harmony Kit contains the components of the Health Harmony Remote Patient Monitoring sys
• 00850040853049: A Health Harmony Kit contains the components of the Health Harmony Remote Patient Monitoring sys
• 00850040853032: A Health Harmony Kit contains the components of the Health Harmony Remote Patient Monitoring sys
• 00850040853025: Health Harmony Mobile is a component of the Health Harmony Remote Patient Monitoring system. It
• 00850040853018: Health Harmony Mobile is a component of the Health Harmony Remote Patient Monitoring system. It
• 00850040853001: Health Harmony Maestro is a component of the Health Harmony Remote Patient Monitoring system. I