Catalog Number

98754

Brand Name

FreeStyle

Version/Model Number

98754

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 15, 2021

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

OUG

Product Code Name

Medical device data system

Public Device Record Key

91cacb01-8941-4f8d-8ffd-2a7bf623a053

Public Version Date

January 15, 2021

Public Version Number

3

DI Record Publish Date

March 16, 2018

Package DI Number

35021791000822

Quantity per Package

50

Contains DI Package

05021791000821

Package Discontinue Date

January 15, 2021

Package Status

Not in Commercial Distribution

Package Type

Case