Catalog Number

023-194

Brand Name

OneTouch Verio Flex

Version/Model Number

023-194

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

LFR

Product Code Name

Glucose dehydrogenase, glucose

Public Device Record Key

d83f840d-be2e-4808-a4d2-24cd29e616ac

Public Version Date

July 26, 2019

Public Version Number

3

DI Record Publish Date

September 13, 2017

Package DI Number

20353885010713

Quantity per Package

4

Contains DI Package

00353885010719

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper case