ByramConnect Rx

GUDID B553BYRAMCONNECTRX100

ByramConnect™ 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. ByramConnect Rx is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. ByramConnect Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, ByramConnect Rx provides coaching messages (motivational, behavioral, and educational) based on real-time blood 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. ByramConnect Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. ByramConnect Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. ByramConnect Rx is not indicated for people with gestational diabetes or who use an insulin pump. IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing an emergency, please dial 911.

WELLDOC, INC.

Pharmaceutical management support software, patient-/professional-use

• Primary Device ID: B553BYRAMCONNECTRX100
• NIH Device Record Key: 055fa139-7a55-4879-90b8-2001afcae4c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ByramConnect Rx
• Version Model Number: v1.0
• 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

Customer Support Contacts

• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com
• Phone: (888) 527-6688
• Email: connect@welldoc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B553BYRAMCONNECTRX100 [Primary]

FDA Product Code

• MRZ: Accessories, Pump, Infusion

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: 2021-10-05
• Device Publish Date: 2021-09-27

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• B553202058OTC0 - Welldoc App for Diabetes in Pregnancy and Insulin Pump Users: 2025-01-06 The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intende
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