Catalog Number

BALPN1635S

Brand Name

BREEZE® APD

Version/Model Number

BALPN1635S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 26, 2022

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FGE

Product Code Name

Stents, drains and dilators for the biliary ducts

Public Device Record Key

b874f845-e6ec-4931-80bb-59eadc678f36

Public Version Date

March 07, 2022

Public Version Number

1

DI Record Publish Date

February 26, 2022

Package DI Number

30884908138826

Quantity per Package

5

Contains DI Package

00884908138825

Package Discontinue Date

February 26, 2022

Package Status

Not in Commercial Distribution

Package Type

inner box