Catalog Number

-

Brand Name

On Call Express Blood Glucose Meter

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

K132086,K132086,K132086,K132086

Product Code

NBW

Product Code Name

SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Public Device Record Key

f0563c35-999c-44a6-96a0-60652bd93583

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

20682607557169

Quantity per Package

6

Contains DI Package

10682607557162

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton