Catalog Number

VYML5D0001

Brand Name

VYGON

Version/Model Number

VYML5D0001

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

1d654ca8-7911-4cfd-8951-9cd437d5cd02

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

March 26, 2020

Package DI Number

30849884000987

Quantity per Package

10

Contains DI Package

00849884000986

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-