Healthfirst Cares

GUDID B553HEALTHFIRST200

Healthfirst Cares 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 is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. Healthfirst Cares analyzes, and reports glucose test results and supports medication adherence. In addition, Healthfirst Cares 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.

WELLDOC, INC.

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• Primary Device ID: B553HEALTHFIRST200
• NIH Device Record Key: 35d2eeb7-52e7-4c3b-a803-83a3ab63c0f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healthfirst Cares
• Version Model Number: v2.0
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B553HEALTHFIRST200 [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: 2023-09-29
• Device Publish Date: 2023-09-21

On-Brand Devices [Healthfirst Cares]

• B553HEALTHFIRST100: Healthfirst Cares is indicated for use by healthcare providers (HCPs) and their patients – age
• B553HEALTHFIRST110: Healthfirst Cares is indicated for use by healthcare providers (HCPs) and their patients – age
• B553HEALTHFIRST200: Healthfirst Cares is indicated for use by healthcare providers (HCPs) and their patients – age