Catalog Number

757102

Brand Name

On Call Express Voice Blood Glucose Meter

Version/Model Number

G117-148

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

K191038,K191038,K191038,K191038

Product Code

NBW

Product Code Name

System, test, blood glucose, over the counter

Public Device Record Key

57a4b612-d03a-4299-bfb6-7aaec9c7820c

Public Version Date

December 24, 2019

Public Version Number

1

DI Record Publish Date

December 16, 2019

Package DI Number

10682607571021

Quantity per Package

4

Contains DI Package

00682607571024

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case