Bluestar

GUDID B553BLUESTAR710

BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar is intended to assist patients in managing their diabetes with guidance from their providers BlueStar® is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. BlueStar analyzes, and reports glucose test results and supports medication adherence. In addition, BlueStar 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. BlueStar 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
Primary Device IDB553BLUESTAR710
NIH Device Record Keyfa359e7e-9312-4ec0-80c1-924f37e6d356
Commercial Distribution StatusIn Commercial Distribution
Brand NameBluestar
Version Model Numberv7.1
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 Usetrue
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

Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com
Phone18884503664
Emailconnect@welldoc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB553BLUESTAR710 [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 Date2022-05-06
Device Publish Date2022-04-28

On-Brand Devices [Bluestar ]

B553BLUESTAR510DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
B553BLUESTAR500DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
B553BLUESTAR420DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
B553BLUESTAR530DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
B553BLUESTAR540DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
B553BLUESTAR550DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
B553BLUESTAR560DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
B553BLUESTAR570DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
B553BLUESTAR610DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
B553BLUESTAR620DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
B553BLUESTARRX710BlueStar® Rx is a Software as a Medical Device (SaMD) intended to be used by healthcare provide
B553BLUESTAR710BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (H
B553BLUESTAR720BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (H
B553202006OTC0BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (H
B553202003OTC0BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (H
B553202001OTC0BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (H

Trademark Results [Bluestar]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BLUESTAR
BLUESTAR
98415258 not registered Live/Pending
Ameritas Life Insurance Corp.
2024-02-21
BLUESTAR
BLUESTAR
98338874 not registered Live/Pending
Howl, Robert C
2024-01-02
BLUESTAR
BLUESTAR
97322901 not registered Live/Pending
CONVERSION ENERGY SYSTEMS, INC
2022-03-21
BLUESTAR
BLUESTAR
97091136 not registered Live/Pending
Liang, Difa
2021-10-25
BLUESTAR
BLUESTAR
90579443 not registered Live/Pending
United Radio Incorporated
2021-03-15
BLUESTAR
BLUESTAR
90579431 not registered Live/Pending
United Radio Incorporated
2021-03-15
BLUESTAR
BLUESTAR
90579406 not registered Live/Pending
United Radio Incorporated
2021-03-15
BLUESTAR
BLUESTAR
90489770 not registered Live/Pending
Vernon Sales Inc.
2021-01-26
BLUESTAR
BLUESTAR
90083608 not registered Live/Pending
Blue Star B.V.
2020-07-30
BLUESTAR
BLUESTAR
90083440 not registered Live/Pending
Blue Star B.V.
2020-07-30
BLUESTAR
BLUESTAR
88904887 not registered Live/Pending
United Radio Incorporated
2020-05-07
BLUESTAR
BLUESTAR
88904878 not registered Live/Pending
United Radio Incorporated
2020-05-07
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