Catalog Number

AMS-636NS

Brand Name

VYGON

Version/Model Number

AMS-636NS

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

c8cf8a62-aff3-4bef-8d1c-bc2f93b39093

Public Version Date

April 10, 2020

Public Version Number

1

DI Record Publish Date

April 02, 2020

Package DI Number

30849884002844

Quantity per Package

2

Contains DI Package

10849884002840

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-