Catalog Number

70469

Brand Name

FreeStyle

Version/Model Number

70469

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)

-

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

0dc427fc-8196-489e-94f7-c9e1ad9f8e32

Public Version Date

July 16, 2018

Public Version Number

1

DI Record Publish Date

June 15, 2018

Package DI Number

30699073130014

Quantity per Package

24

Contains DI Package

00699073130013

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case