Catalog Number

-

Brand Name

Freemie

Version/Model Number

FG116

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)

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

cc0550c5-eaa7-4658-b743-f821d8efaee1

Public Version Date

September 08, 2021

Public Version Number

1

DI Record Publish Date

August 31, 2021

Package DI Number

10851690007612

Quantity per Package

100

Contains DI Package

00851690007615

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case