Duns Number:021217115
Device Description: DIABETES SUPPORT, ANYTIME ANYWHERE™BlueStar is not a pill or a shot — it's a completely ne
Catalog Number
-
Brand Name
BlueStar
Version/Model Number
v5.5
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 16, 2020
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
e41d4d25-8519-4fd6-89e0-c77c19376d1a
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
April 13, 2020
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 |