Catalog Number

63.00.190

Brand Name

Amaryll

Version/Model Number

63.00.190

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

0386ddd0-743a-409c-9c39-ccdd5644f71b

Public Version Date

August 12, 2022

Public Version Number

1

DI Record Publish Date

August 04, 2022

Package DI Number

00814079020100

Quantity per Package

10

Contains DI Package

00814079020094

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box