Health Harmony

GUDID 00850040853056

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.

Care Innovations, LLC

Multiple physiological parameter spot-check system, home-use

• Primary Device ID: 00850040853056
• NIH Device Record Key: c2282903-f22c-46c2-89ab-0a41ff2e92c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health Harmony
• Version Model Number: Kit RPM - Hub
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00850040853056 [Primary]

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: 2022-10-06
• Device Publish Date: 2022-09-28

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