Catalog Number

02404201

Brand Name

OneTouch Verio Blood Glucose Monitoring System.

Version/Model Number

024042

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

K131363,K131363

Product Code

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Public Device Record Key

1ab1da67-079d-4134-bc1b-1d6c5577508f

Public Version Date

March 21, 2019

Public Version Number

1

DI Record Publish Date

March 13, 2019

Package DI Number

20353885011819

Quantity per Package

10

Contains DI Package

00353885011815

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shipper case