Catalog Number

-

Brand Name

CVS Health

Version/Model Number

8000-10291

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

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

aec32d6a-0e53-4af5-bb82-1dd0797241a9

Public Version Date

March 30, 2021

Public Version Number

1

DI Record Publish Date

March 22, 2021

Package DI Number

00050428293300

Quantity per Package

1

Contains DI Package

10050428293307

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton