FDA UDI
In Commercial Distribution
🇺🇸 United States
Health Harmony
DI: 00850040853032
·
Model: Kit RPM - Mobile
·
Care Innovations, LLC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Health Harmony
- Primary DI
- 00850040853032
- Version / Model
- Kit RPM - Mobile
- Company Name
- Care Innovations, LLC
- Labeler DUNS
- 966632304
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-28
- Public Version
- 2
- Public Version Date
- 2022-10-10
- Public Version Status
- Update
- Public Device Record Key
- 7116f8b1-a114-4b85-a3a1-89ad8ab1a5f8
Device Description
A Health Harmony Kit contains the components of the Health Harmony Remote Patient Monitoring system that are needed by the patient. A Health Harmony Mobile Kit contains a personal mobile device pre-loaded with Health Harmony Mobile software that has been setup for the patient. The kit will also contain any Bluetooth medical devices (e.g. a weight scale or a pulse oximeter) that have been selected by the healthcare provider for remote collection of patient vital signs.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48041 | Multiple physiological parameter spot-check system, home-use | An electrically-powered device assembly designed for use in the home to spot-check (user-initiated) measure and display multiple patient physiological parameters [e.g., blood pressure, blood glucose, pulse rate, temperature, haemoglobin oxygen saturation (SpO2), and possibly calculate mean arterial pressure (MAP)]. It typically includes a main unit with a visual display intended to process/store the data, and physiological measuring components (e.g., thermometer, blood pressure cuff, blood glucose meter); it may additionally allow the data to be communicated with a healthcare professional. It may be used in a healthcare facility and in the home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850040853032 | GS1 |