Duns Number:021217115
Device Description: DIABETES SUPPORT, ANYTIME ANYWHERE™BlueStar is not a pill or a shot — it's a completely ne DIABETES SUPPORT, ANYTIME ANYWHERE™BlueStar 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. BlueStar’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.BlueStar 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 BlueStar 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 USEBlueStar is indicated for use by healthcare providers and their adult patients, aged 21 years and older, who have type 2 diabetes.BlueStar provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, andeducational coaching messages to aid in diabetes self-management. BlueStar 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
Catalog Number
-
Brand Name
BlueStar
Version/Model Number
v5.3
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 25, 2019
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MRZ
Product Code Name
Accessories, Pump, Infusion
Public Device Record Key
8a7b33eb-5a78-4f7b-9c0d-523d9a39381c
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
October 22, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 56 |