Catalog Number

63.00.191

Brand Name

Amaryll Start

Version/Model Number

63.00.191

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

32d3c124-c324-4d6d-a370-68b3d71fc36a

Public Version Date

October 25, 2018

Public Version Number

1

DI Record Publish Date

September 24, 2018

Package DI Number

00814079021398

Quantity per Package

10

Contains DI Package

00814079021381

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box