Catalog Number

BN-602

Brand Name

VYGON

Version/Model Number

BN-602

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

K011336,K011336

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

cfa50591-c020-43b9-8a50-e0854f18be32

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 07, 2016

Package DI Number

38498840009889

Quantity per Package

50

Contains DI Package

08498840009888

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-