Catalog Number

-

Brand Name

Bellema

Version/Model Number

XN-2201M3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

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

d6676a2d-3ee5-4679-8bac-c9631483e930

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 23, 2017

Package DI Number

36940657922018

Quantity per Package

12

Contains DI Package

06940657922017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton