Catalog Number

-

Brand Name

OneTouch Ultrasoft

Version/Model Number

011-423

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

Yes

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

FMK

Product Code Name

Lancet, Blood

Public Device Record Key

260a47c1-c4db-4263-8f30-5ed49da6fbdd

Public Version Date

October 08, 2021

Public Version Number

1

DI Record Publish Date

September 30, 2021

Package DI Number

20353885012441

Quantity per Package

450

Contains DI Package

00353885012447

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper case