Catalog Number

01181803

Brand Name

OneTouch Verio Control Solution

Version/Model Number

011818

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

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

89d7cf85-84e0-4f5d-a4de-8647f5642654

Public Version Date

October 22, 2020

Public Version Number

1

DI Record Publish Date

October 14, 2020

Package DI Number

20353885011963

Quantity per Package

1000

Contains DI Package

00353885011969

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-