Catalog Number

020-393

Brand Name

OneTouch Ultrasoft

Version/Model Number

020-393

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

47e52ab8-a893-430b-8a9d-8f0bcd4c6b71

Public Version Date

December 03, 2019

Public Version Number

1

DI Record Publish Date

November 25, 2019

Package DI Number

20353885393106

Quantity per Package

24

Contains DI Package

00353885393102

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper case