Health Harmony

Primary DI
00850040853056
Brand
Health Harmony
Company
Care Innovations, LLC
Model
Kit RPM - Hub
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 Hub Kit is for patients that do not use the Health Harmony Mobile application. (This is a viable option when the collection of vital signs alone provides adequate information for the clinician to remotely manage the patient.) The kit contains an interface hub device and 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
00850040853056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850040853056008500408530568500408530560850040853056

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
00850040853032Health HarmonyKit RPM - Mobile2022-09-28
00850040853049Health HarmonyKit RPM - BYOD2022-09-28