Catalog Number

-

Brand Name

Bellema

Version/Model Number

XN-2203H4

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

3b4ed4d7-9273-4131-9737-dbadbd11cb67

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 24, 2016

Package DI Number

36940657921011

Quantity per Package

4

Contains DI Package

06940657921010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case