Catalog Number

246.06

Brand Name

VYGON

Version/Model Number

246.06

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

6880b1ae-ef9a-443c-81e8-8056fa4da422

Public Version Date

October 22, 2018

Public Version Number

4

DI Record Publish Date

September 14, 2016

Package DI Number

53660812002955

Quantity per Package

40

Contains DI Package

33660812002951

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-