Health Harmony
Basic Information
- Brand Name
- Health Harmony
- Primary DI
- 00850040853001
- Version / Model
- Maestro RPM
- Company Name
- Care Innovations, LLC
- Labeler DUNS
- 966632304
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-17
- Public Version
- 1
- Public Version Date
- 2022-10-25
- Public Version Status
- New
- Public Device Record Key
- b0595edb-870d-4ae6-ac5b-0eb40d664f94
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JQP | Calculator/Data Processing Module, For Clinical Use | Clinical Chemistry | 862.2100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850040853001 | GS1 |