Health Harmony

GUDID 00850040853001

Health Harmony Maestro is a component of the Health Harmony Remote Patient Monitoring system. It is a web-based software application that is used by healthcare providers for clinical data management and communication with patients. The Health Harmony Maestro dashboard provides a snapshot of patient data including vital signs and answers to symptom and behavior questions. Patient responses and medical device readings are risk stratified based on customer and/or individual thresholds set by the clinician. Alerts display on the dashboard triage page by the most recent date. At a glance, the clinician is able to detect patient data that is outside of threshold settings. Beyond the dashboard, detailed information may be viewed at a patient level as indicated. Clinicians can send messages to the patient that will be displayed on the Health Harmony Mobile application. Video conferencing between the clinician and patient is also available within the Health Harmony applications.

Care Innovations, LLC

Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only Vulnerable patient home-monitoring software, professional-only

• Primary Device ID: 00850040853001
• NIH Device Record Key: b0595edb-870d-4ae6-ac5b-0eb40d664f94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health Harmony
• Version Model Number: Maestro RPM
• 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	00850040853001 [Primary]

FDA Product Code

• JQP: Calculator/Data Processing Module, For Clinical Use

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