Catalog Number

VAMST3.5

Brand Name

VYGON

Version/Model Number

VAMST3.5

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

-

Product Code

OWL

Product Code Name

Peripheral catheter insertion kit

Public Device Record Key

b711d779-ac64-4987-9a26-2814dbb91d75

Public Version Date

January 31, 2020

Public Version Number

1

DI Record Publish Date

January 23, 2020

Package DI Number

30849884004169

Quantity per Package

10

Contains DI Package

00849884004168

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-