Catalog Number

010-458

Brand Name

OneTouch Ultra

Version/Model Number

010-458

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

K103553,K103553,K103553

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

b47b12ae-dee3-4ef9-9815-71aadd1f496f

Public Version Date

August 10, 2020

Public Version Number

1

DI Record Publish Date

July 31, 2020

Package DI Number

20353885458027

Quantity per Package

48

Contains DI Package

00353885458023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper case