Health Harmony

Primary DI
00850040853032
Brand
Health Harmony
Company
Care Innovations, LLC
Model
Kit RPM - Mobile
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.
Published
2022-09-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850040853032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850040853032008500408530328500408530320850040853032

GMDN Terms#

Term, Definition table
TermDefinition
Multiple physiological parameter spot-check system, home-useAn 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 analysis unit with a visual display, and ports for input of the system's measuring components (e.g., thermometer, blood pressure cuff, blood glucose meter) or external devices (e.g., USB cable). It may be used in a healthcare facility and in the home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
966632304
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850040853001Health HarmonyMaestro RPM2022-10-17
00850040853018Health HarmonyMobile RPM - BYOD2022-10-17
00850040853025Health HarmonyMobile RPM - Enterprise2022-10-17
00850040853049Health HarmonyKit RPM - BYOD2022-09-28
00850040853056Health HarmonyKit RPM - Hub2022-09-28