Catalog Number

AMS-290

Brand Name

VYGON

Version/Model Number

AMS-290

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

K013949,K013949

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

72e59fff-770c-4d07-9bdc-64b425538c43

Public Version Date

July 23, 2020

Public Version Number

2

DI Record Publish Date

October 31, 2019

Package DI Number

30849884002523

Quantity per Package

100

Contains DI Package

00849884002522

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-