BlueStar - DIABETES SUPPORT, ANYTIME ANYWHERE™BlueStar is - WELLDOC, INC.

Duns Number:021217115

Device Description: DIABETES SUPPORT, ANYTIME ANYWHERE™BlueStar is not a pill or a shot — it's a completely ne

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More Product Details

Catalog Number

-

Brand Name

BlueStar

Version/Model Number

v6.2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

MRZ

Product Code Name

Accessories, Pump, Infusion

Device Record Status

Public Device Record Key

50fd5e0f-a89f-42dd-805e-25c058a855a1

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

January 14, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WELLDOC, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 56