Catalog Number

AMS-427-NS

Brand Name

VYGON

Version/Model Number

AMS-427-NS

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

4d26171a-11a4-4bee-9cc5-2503ac526e58

Public Version Date

April 09, 2020

Public Version Number

1

DI Record Publish Date

April 01, 2020

Package DI Number

30849884002608

Quantity per Package

1000

Contains DI Package

10849884002604

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-