Catalog Number

246.042

Brand Name

VYGON

Version/Model Number

246.042

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

73e4ed77-8983-4151-8ef1-9efdbcadccab

Public Version Date

October 22, 2018

Public Version Number

4

DI Record Publish Date

September 13, 2016

Package DI Number

53660812033119

Quantity per Package

40

Contains DI Package

33660812033115

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-