Catalog Number

57063

Brand Name

Pump In Style Advanced

Version/Model Number

PNSA 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

K031614,K031614,K031614,K031614

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Public Device Record Key

f18edd56-33d0-432d-aa56-3d82d403e1db

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10020451570638

Quantity per Package

3

Contains DI Package

00020451570631

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton