Catalog Number

021-105

Brand Name

OneTouch Ultra2

Version/Model Number

021-105

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

K053529,K053529

Product Code

CGA

Product Code Name

GLUCOSE OXIDASE, GLUCOSE

Public Device Record Key

01e4d4d1-46fb-427b-a53b-92e7bfb95dd7

Public Version Date

July 26, 2019

Public Version Number

4

DI Record Publish Date

September 13, 2017

Package DI Number

20353885008376

Quantity per Package

32

Contains DI Package

00353885008372

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper case