Catalog Number

-

Brand Name

The Pump by Babyation

Version/Model Number

BP1

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

K173699,K173699,K173699,K173699,K173699

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Public Device Record Key

4fea2acb-28de-4d58-903e-26edae5b56e1

Public Version Date

October 03, 2022

Public Version Number

2

DI Record Publish Date

May 25, 2022

Package DI Number

00850004964019

Quantity per Package

1

Contains DI Package

00850004964002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-