Catalog Number

-

Brand Name

On Call Express Blood Glucose Monitor

Version/Model Number

G115-11D

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

532b8c3c-0abe-4a37-87c6-0955b9d994ea

Public Version Date

April 07, 2020

Public Version Number

1

DI Record Publish Date

March 30, 2020

Package DI Number

10024291121821

Quantity per Package

3

Contains DI Package

00024291121824

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON