Catalog Number

-

Brand Name

Cornerstones4Care® Powered by Glooko Mobile Application

Version/Model Number

1.xx

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

PHV

Product Code Name

Continuous Glucose Monitor Retrospective Data Analysis Software

Public Device Record Key

9cbe91e0-519c-4f53-8639-0e89d67068c1

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

February 16, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-