Catalog Number

-

Brand Name

OneTouch Ultra Plus

Version/Model Number

024-282

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

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Public Device Record Key

34a5d509-7cb5-4fe3-a293-c6a7b034cdd4

Public Version Date

September 08, 2022

Public Version Number

1

DI Record Publish Date

August 31, 2022

Package DI Number

20353885012687

Quantity per Package

48

Contains DI Package

00353885012683

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper case