Catalog Number

VYML4S0001

Brand Name

VYGON

Version/Model Number

VYML4S0001

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

584b77f5-e6b3-4ebd-bdcf-776d88c70338

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 26, 2019

Package DI Number

38498840012018

Quantity per Package

10

Contains DI Package

08498840012017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-