Catalog Number

-

Brand Name

OneTouch Lancing Device

Version/Model Number

021-242

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)

-

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

c2228549-3fa4-43c8-81eb-23ee782d11b6

Public Version Date

April 21, 2020

Public Version Number

1

DI Record Publish Date

April 13, 2020

Package DI Number

20353885012120

Quantity per Package

140

Contains DI Package

00353885012126

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper case