BlueStarRx

Primary DI
B553BLUESTARRX430
Brand
BlueStarRx
Company
WELLDOC, INC.
Model
v4.3
Device description
DIABETES SUPPORT, ANYTIME ANYWHERE™BlueStarRx is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 2diabetes. BlueStarRx’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works withyou, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes fora healthier, happier you.BlueStarRx is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions whileproviding you with diabetes education and motivational support.COORDINATE YOUR CARE WITH YOUR DOCTORBefore your next diabetes check-up, you can use BlueStarRx to send your information to your doctor. This helps your healthcareprovider understand the challenges that you face between appointments so that during your office visit you can discuss atreatment plan that is just right for you.INDICATION FOR USEBlueStarRx is indicated for use by healthcare providers and their adult patients, aged 21 years and older, who have type 2 diabetes.BlueStarRx provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, andeducational coaching messages to aid in diabetes self-management. BlueStarRx is not intended to replace the care provided by alicensed healthcare professional, including prescriptions, diagnosis, or treatment.CONTRAINDICATIONS: Type 1 diabetes, patients on insulin pumps, patients less than 21 years of age, and women who arepregnant.IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing anemergency, please dial 911.Caution: Federal law restricts this device to sale by or on the order of a physician.For more information visit www.bluestardiabetes.com
Published
2018-06-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRZAccessories, Pump, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRZAccessories, Pump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162532000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162532000WellDoc BlueStar, WellDoc BlueStar RxWelldoc, Inc.2017-01-12MRZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B553BLUESTARRX420PreviousHIBCC0
B553BLUESTARRX430PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Home pharmaceutical management support softwareA software package intended to be used by patients at home, and healthcare professionals in a clinical setting, to facilitate therapeutic pharmaceutical management decisions (e.g., dosage) by providing suggested regimes for individual patients based on their physical and laboratory data. It is intended to be used on a non-medical computerized device (e.g., to be used on mobile devices at point-of-care); it is not intended to support anaesthesia administration.

Contacts#

Phone, Email table
PhoneEmail
888-611-4794connect@welldoc.com

Regulatory Flags#

DUNS number
021217115
Device count
1
Lot or batch
true

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