Catalog Number

17451

Brand Name

Ameda

Version/Model Number

HygieniKit Plus

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

OHH

Product Code Name

Breast Pump Kit

Public Device Record Key

e21083c2-77a8-464c-a120-7c4227538ff5

Public Version Date

May 05, 2021

Public Version Number

1

DI Record Publish Date

April 27, 2021

Package DI Number

00810725025437

Quantity per Package

12

Contains DI Package

00810725022405

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton