Catalog Number

-

Brand Name

Freemie

Version/Model Number

FG022

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2020

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

K130349,K130349

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Public Device Record Key

06109cbc-377e-4e56-9736-76811cd3ff0b

Public Version Date

August 31, 2021

Public Version Number

4

DI Record Publish Date

October 02, 2016

Package DI Number

10851690007070

Quantity per Package

12

Contains DI Package

00851690007073

Package Discontinue Date

December 31, 2020

Package Status

Not in Commercial Distribution

Package Type

Case