Catalog Number

VYML5D1002

Brand Name

VYGON

Version/Model Number

VYML5D1002

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

K181208,K181208

Product Code

PND

Product Code Name

Midline catheter

Public Device Record Key

8ebbff63-6d37-4497-a0fa-0985ae9f2012

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

January 22, 2021

Package DI Number

30849884005159

Quantity per Package

5

Contains DI Package

00849884005158

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-