Health Harmony

GUDID 00850040853032

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.

Care Innovations, LLC

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• Primary Device ID: 00850040853032
• NIH Device Record Key: 7116f8b1-a114-4b85-a3a1-89ad8ab1a5f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health Harmony
• Version Model Number: Kit RPM - Mobile
• 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	00850040853032 [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