Conifer Connect Diabetes

GUDID B553CCDIABETES110

Conifer Connect includes Conifer Connect Diabetes and Conifer Connect Diabetes Rx, which is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older – who have type 1 or type 2 diabetes. Conifer Connect Diabetes and Conifer Connect Diabetes Rx are intended to assist patients in managing their diabetes with guidance from their providers. Conifer Connect Diabetes Rx requires a prescription.

WELLDOC, INC.

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• Primary Device ID: B553CCDIABETES110
• NIH Device Record Key: 79769569-b96c-4d00-b6ce-e0aeb8a22629
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Conifer Connect Diabetes
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B553CCDIABETES110 [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: 2024-02-15
• Device Publish Date: 2024-02-07

On-Brand Devices [Conifer Connect Diabetes]

• B553CCDIABETES100: Conifer Connect includes Conifer Connect Diabetes and Conifer Connect Diabetes Rx, which is a So
• B553CCDIABETES110: Conifer Connect includes Conifer Connect Diabetes and Conifer Connect Diabetes Rx, which is a So