Catalog Number

AMS-8182

Brand Name

VYGON

Version/Model Number

AMS-8182

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

203979f6-1958-4bf9-88d7-404d90a04cfc

Public Version Date

December 17, 2020

Public Version Number

1

DI Record Publish Date

December 09, 2020

Package DI Number

30849884003148

Quantity per Package

50

Contains DI Package

00849884003147

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-