ByramConnect

GUDID B553BYRAMCONNECT100

ByramConnect™ 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 is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. ByramConnect analyzes and reports blood glucose test results and supports medication adherence. In addition, ByramConnect 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 is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. ByramConnect 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: B553BYRAMCONNECT100
• NIH Device Record Key: 3e490ac5-619f-4ee3-aa66-fbf365e64a9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ByramConnect
• 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	B553BYRAMCONNECT100 [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
• B553202141OTC0 - LivingConnected Diabetes Rx: 2024-12-12 LivingConnected® powered by CCS Health (“LivingConnected”) includes LivingConnected Diabetes and LivingConnected Diabetes R
• B553202142RX0 - LivingConnected Diabetes: 2024-12-12 LivingConnected® powered by CCS Health (“LivingConnected”) includes LivingConnected Diabetes and LivingConnected Diabetes R
• B553202143OTC0 - LivingConnected Diabetes: 2024-12-12 LivingConnected® powered by CCS Health (“LivingConnected”) includes LivingConnected Diabetes and LivingConnected Diabetes R
• B553202144RX0 - LivingConnected Diabetes Rx: 2024-12-12 LivingConnected® powered by CCS Health (“LivingConnected”) includes LivingConnected Diabetes and LivingConnected Diabetes R
• B553202001OTC0 - Bluestar: 2024-10-02 BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged
• B553202002RX0 - Bluestar Rx: 2024-10-02 BlueStar® Rx is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients –