Catalog Number

101038299

Brand Name

Pump In Style Advanced

Version/Model Number

Advanced Personal Double Breast Pump

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

K031614,K031614

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Public Device Record Key

b917d99a-251c-4883-88e2-61cbf71222b7

Public Version Date

April 29, 2019

Public Version Number

1

DI Record Publish Date

April 19, 2019

Package DI Number

20020451382993

Quantity per Package

3

Contains DI Package

00020451382999

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton