Catalog Number

-

Brand Name

Gentle Feed

Version/Model Number

MQ9100

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

-

Product Code

HGX

Product Code Name

PUMP, BREAST, POWERED

Public Device Record Key

0b89c2f1-e725-4a88-80ba-afb0d9ae7210

Public Version Date

April 25, 2018

Public Version Number

3

DI Record Publish Date

July 01, 2016

Package DI Number

10822383539512

Quantity per Package

6

Contains DI Package

00822383539515

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-