Catalog Number

AMS-664-2

Brand Name

VYGON

Version/Model Number

AMS-664-2

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

K882503,K882503

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

6aa113ac-7c8b-40c4-874d-fc7f795ecdb7

Public Version Date

June 10, 2020

Public Version Number

1

DI Record Publish Date

June 02, 2020

Package DI Number

30849884002868

Quantity per Package

1000

Contains DI Package

10849884002864

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-