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 Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software
Primary Device IDB553BYRAMCONNECT100
NIH Device Record Key3e490ac5-619f-4ee3-aa66-fbf365e64a9b
Commercial Distribution StatusIn Commercial Distribution
Brand NameByramConnect
Version Model Numberv1.0
Company DUNS021217115
Company NameWELLDOC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com
Phone(888) 527-6688
Emailconnect@welldoc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB553BYRAMCONNECT100 [Primary]

FDA Product Code

MRZAccessories, Pump, Infusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-05
Device Publish Date2021-09-27

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