Catalog Number

024-047

Brand Name

OneTouch Ultra2 Blood Glucose Monitoring System.

Version/Model Number

024-047

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

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

87fafd02-6e3f-4e6a-b463-40497834894e

Public Version Date

September 02, 2022

Public Version Number

2

DI Record Publish Date

March 12, 2019

Package DI Number

20353885011864

Quantity per Package

10

Contains DI Package

00353885011860

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shipper case