Catalog Number

755014

Brand Name

On Call Express Mobile Blood Glucose Meter

Version/Model Number

G115-14S

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

K180196,K180196,K180196,K180196

Product Code

NBW

Product Code Name

System, test, blood glucose, over the counter

Public Device Record Key

839be6a1-5e31-4caa-984a-b492a6340bf2

Public Version Date

December 11, 2019

Public Version Number

2

DI Record Publish Date

June 14, 2019

Package DI Number

10682607550149

Quantity per Package

4

Contains DI Package

00682607550142

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case