Catalog Number

AMS-400

Brand Name

VYGON

Version/Model Number

AMS-400

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

K012157,K012157

Product Code

FMG

Product Code Name

Stopcock, i.V. Set

Public Device Record Key

643d063a-fcea-4fc4-9c19-15bcde1dbcb9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 04, 2016

Package DI Number

38498840001012

Quantity per Package

100

Contains DI Package

08498840001011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-