AccessGUDID - DEVICE: Health Harmony (00850040853049)

GUDID

Device Identifier (DI) Information

Brand Name: Health Harmony
Version or Model: Kit RPM - BYOD
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Care Innovations, LLC

Primary DI Number: 00850040853049
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 966632304 *Terms of Use

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 BYOD Kit is for patients that download and use the Health Harmony Mobile application on their own personal mobile device. The kit will 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 54c4f370-2680-40d8-8feb-d9e5e8a9e57b
Public Version Date: April 12, 2024
Public Version Number: 3
DI Record Publish Date: September 28, 2022