Healthfirst Cares Rx

GUDID B553HEALTHFIRSTRX1108

Healthfirst Cares Rx is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Healthfirst Cares Rx is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. Healthfirst Cares Rx analyzes, and reports glucose test results and supports medication adherence. In addition, Healthfirst Cares Rx provides coaching messages (motivational, behavioral, and educational) based on real-time glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. The following Healthfirst Cares Rx insulin management feature is for prescription use only: For bolus insulin users with type 1 or type 2 diabetes, Healthfirst Cares Rx includes an insulin dose calculator* to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or glucose value. Healthfirst Cares Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

WELLDOC, INC.

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• Primary Device ID: B553HEALTHFIRSTRX1108
• NIH Device Record Key: f6f3285b-6eab-406c-bdc4-8076f73844ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healthfirst Cares Rx
• Version Model Number: v1.1
• Company DUNS: 021217115
• Company Name: WELLDOC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B553HEALTHFIRSTRX1108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203434

FDA Product Code

• NDC: Calculator, Drug Dose

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: 2023-03-14
• Device Publish Date: 2023-03-06

On-Brand Devices [Healthfirst Cares Rx]

• B553HEALTHFIRSTRX1007: Healthfirst Cares Rx is indicated for use by healthcare providers (HCPs) and their patients –
• B553HEALTHFIRSTRX1108: Healthfirst Cares Rx is indicated for use by healthcare providers (HCPs) and their patients –
• B553HEALTHFIRSTRX200: Healthfirst Cares Rx is indicated for use by healthcare providers (HCPs) and their patients –