Catalog Number

10012

Brand Name

Ameda, Inc.

Version/Model Number

10012

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

K011519,K011519

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Public Device Record Key

691cc078-1a04-4bf3-b990-1e0b61235fca

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10810725023140

Quantity per Package

10

Contains DI Package

00810725023143

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Carton