Catalog Number

-

Brand Name

Freestyle Flex

Version/Model Number

101037980

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

K191653,K191653

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Public Device Record Key

38a9baa2-a29a-428e-b03d-91b40ad527a1

Public Version Date

October 30, 2019

Public Version Number

1

DI Record Publish Date

October 22, 2019

Package DI Number

07612367065863

Quantity per Package

1

Contains DI Package

07612367071918

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-