Catalog Number

BN-160

Brand Name

VYGON

Version/Model Number

BN-160

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

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

K013950,K013950

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

ff44f63b-075f-46be-a2ad-8303a184c0f5

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

January 28, 2020

Package DI Number

30849884003667

Quantity per Package

100

Contains DI Package

00849884003666

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-