Catalog Number

AMS-539-3

Brand Name

VYGON

Version/Model Number

AMS-539-3

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

-

Product Code

OJA

Product Code Name

Intravenous extension tubing set

Public Device Record Key

d3152274-a006-46e9-88ee-66ab4cb6a3a3

Public Version Date

November 01, 2022

Public Version Number

1

DI Record Publish Date

October 24, 2022

Package DI Number

30849884006002

Quantity per Package

12

Contains DI Package

00849884006001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-