Catalog Number

VYLF1004

Brand Name

VYGON

Version/Model Number

VYLF1004

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

K141026,K141026

Product Code

FOZ

Product Code Name

Catheter, intravascular, therapeutic, short-term less than 30 days

Public Device Record Key

e291becd-91dd-479d-ab97-f61a77617aa4

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

October 29, 2019

Package DI Number

30849884004398

Quantity per Package

10

Contains DI Package

00849884004397

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-