Healthfirst Cares Rx

GUDID B553HEALTHFIRSTRX1007

Healthfirst Cares 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. Healthfirst Cares Rx is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. Healthfirst Cares Rx analyzes, and reports glucose test results and supports medication adherence. In addition, Healthfirst Cares Rx provides coaching messages (motivational, behavioral, and educational) based on real-time 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. The following Healthfirst Cares Rx insulin management feature is for prescription use only: For bolus insulin users with type 1 or type 2 diabetes, Healthfirst Cares Rx includes an insulin dose calculator* to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or glucose value. Healthfirst Cares Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

WELLDOC, INC.

Home pharmaceutical management support software
Primary Device IDB553HEALTHFIRSTRX1007
NIH Device Record Key0ac64ba6-740a-41fb-9a1f-e569d2214a88
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealthfirst Cares Rx
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB553HEALTHFIRSTRX1007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NDCCalculator, Drug Dose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-10
Device Publish Date2022-11-02

On-Brand Devices [Healthfirst Cares Rx]

B553HEALTHFIRSTRX1007Healthfirst Cares Rx is indicated for use by healthcare providers (HCPs) and their patients –
B553HEALTHFIRSTRX1108Healthfirst Cares Rx is indicated for use by healthcare providers (HCPs) and their patients –
B553HEALTHFIRSTRX200Healthfirst Cares Rx is indicated for use by healthcare providers (HCPs) and their patients –
B553202135RX0Healthfirst Cares Rx is indicated for use by healthcare providers (HCPs) and their patients –
B553202134RX0Healthfirst Cares Rx is indicated for use by healthcare providers (HCPs) and their patients –
B553202132RX0Healthfirst Cares Rx is indicated for use by healthcare providers (HCPs) and their patients –
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