Catalog Number

757108

Brand Name

On Call Express II Blood Glucose Meter

Version/Model Number

G117-14A

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

K192175,K192175,K192175,K192175

Product Code

NBW

Product Code Name

System, test, blood glucose, over the counter

Public Device Record Key

0f221381-c485-4ef4-bb3b-a35c2a46febe

Public Version Date

September 14, 2020

Public Version Number

2

DI Record Publish Date

December 16, 2019

Package DI Number

10682607571083

Quantity per Package

4

Contains DI Package

00682607571086

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case