Catalog Number

-

Brand Name

Pump In Style

Version/Model Number

101041360

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

K200508,K200508

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Public Device Record Key

ac3aa081-6859-4b88-838a-f984b27cb216

Public Version Date

July 20, 2020

Public Version Number

1

DI Record Publish Date

July 10, 2020

Package DI Number

10020451401444

Quantity per Package

1

Contains DI Package

00020451401447

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton