Catalog Number

101036451

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

K181937,K181937

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Public Device Record Key

4dd58167-54b5-4d0c-8b47-5866216b6c6e

Public Version Date

June 11, 2019

Public Version Number

1

DI Record Publish Date

June 03, 2019

Package DI Number

10020451364510

Quantity per Package

1

Contains DI Package

00020451364513

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton