Catalog Number

AMS-100

Brand Name

VYGON

Version/Model Number

AMS-100

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

48a553b5-5385-48ae-bf1e-fd68f77fabfb

Public Version Date

November 08, 2019

Public Version Number

1

DI Record Publish Date

October 31, 2019

Package DI Number

30849884002493

Quantity per Package

100

Contains DI Package

00849884002492

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-