Catalog Number

AMS-283

Brand Name

VYGON

Version/Model Number

AMS-283

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

e449c57d-524c-450a-95fe-b4eda2f1b97b

Public Version Date

February 10, 2021

Public Version Number

1

DI Record Publish Date

February 02, 2021

Package DI Number

30849884005111

Quantity per Package

50

Contains DI Package

00849884005110

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-