Catalog Number

18001

Brand Name

Ameda

Version/Model Number

True Protect

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

HGY

Product Code Name

Pump, Breast, Non-Powered

Public Device Record Key

d14cf43f-af33-4104-87c4-10699c22d7f5

Public Version Date

October 18, 2022

Public Version Number

1

DI Record Publish Date

October 10, 2022

Package DI Number

10810725025823

Quantity per Package

24

Contains DI Package

00810725025826

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-