Catalog Number

-

Brand Name

Freestyle

Version/Model Number

Freestyle Tote

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"

Yes

For Single-Use

-

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

K150499,K150499,K150499

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Public Device Record Key

39096de9-230f-4746-9c76-44e27ae9d362

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 01, 2017

Package DI Number

20020451330925

Quantity per Package

2

Contains DI Package

00020451330921

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton