Catalog Number

-

Brand Name

Viverity

Version/Model Number

ROS-DBDX

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 07, 2019

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

258bd4a4-a6d5-4b17-9d76-6cadd7c310f1

Public Version Date

May 08, 2019

Public Version Number

3

DI Record Publish Date

October 05, 2016

Package DI Number

80092237612251

Quantity per Package

6

Contains DI Package

00092237612255

Package Discontinue Date

May 07, 2019

Package Status

Not in Commercial Distribution

Package Type

CA