Catalog Number

VYG-423-1

Brand Name

VYGON

Version/Model Number

VYG-423-1

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

K894954,K894954

Product Code

FPB

Product Code Name

Filter, infusion line

Public Device Record Key

76a7d447-05ad-43ce-b0a4-1d2370fe7721

Public Version Date

February 04, 2020

Public Version Number

1

DI Record Publish Date

January 27, 2020

Package DI Number

30849884004329

Quantity per Package

50

Contains DI Package

00849884004328

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-