Catalog Number

AMS-934-1

Brand Name

VYGON

Version/Model Number

AMS-934-1

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

K011336,K011336

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

0be2f8fb-399c-4a13-ab95-58de55904d50

Public Version Date

April 07, 2020

Public Version Number

1

DI Record Publish Date

March 30, 2020

Package DI Number

30849884003452

Quantity per Package

100

Contains DI Package

00849884003451

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-