PlusRx

GUDID B553PLUSRX110

The Plus® Rx System is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. The Plus® Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The Plus® Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the Plus® Rx System 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. Plus® 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. The Plus® Rx System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

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 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Primary Device IDB553PLUSRX110
NIH Device Record Key02b67fad-8494-40de-9ede-6cf7e7eaf17e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlusRx
Version Model Numberv1.1
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

Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
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Emailconnect@welldoc.com
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Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB553PLUSRX110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2021-07-06
Device Publish Date2021-06-28

On-Brand Devices [PlusRx]

B553PLUSRX100The Plus® Rx System is indicated for use by healthcare providers (HCPs) and their patients –
B553PLUSRX110The Plus® Rx System is indicated for use by healthcare providers (HCPs) and their patients –
B553PLUSRX120The Plus® Rx System is indicated for use by healthcare providers (HCPs) and their patients –

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