Catalog Number

-

Brand Name

Duo Double Electric Breast Pump

Version/Model Number

MD-20.2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K160274,K160274,K160274,K160274,K160274

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Public Device Record Key

6b85cd20-5e7c-4829-9e6a-55ac8d5f8a92

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

January 26, 2017

Package DI Number

00887529000175

Quantity per Package

1

Contains DI Package

00887529000151

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Gift Box