Catalog Number

VYPL5T3003A

Brand Name

VYGON

Version/Model Number

VYPL5T3003A

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

K172899,K172899

Product Code

LJS

Product Code Name

Catheter, intravascular, therapeutic, long-term greater than 30 days

Public Device Record Key

b5f610de-5d78-452d-a095-c8b284673ed7

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

April 14, 2020

Package DI Number

30849884004961

Quantity per Package

4

Contains DI Package

00849884004960

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-