Catalog Number

-

Brand Name

Freemie

Version/Model Number

FG064

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,K130349

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Public Device Record Key

8317c5ef-abd3-427b-80cc-03177cb80f33

Public Version Date

September 08, 2021

Public Version Number

1

DI Record Publish Date

August 31, 2021

Package DI Number

10851690007506

Quantity per Package

12

Contains DI Package

00851690007509

Package Discontinue Date

August 31, 2021

Package Status

Not in Commercial Distribution

Package Type

Case