Catalog Number

AMS-395-1

Brand Name

VYGON

Version/Model Number

AMS-395-1

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

K884370,K884370

Product Code

FPK

Product Code Name

Tubing, fluid delivery

Public Device Record Key

f5c8cc6b-314d-435d-8108-b6780a544fba

Public Version Date

November 08, 2019

Public Version Number

1

DI Record Publish Date

October 31, 2019

Package DI Number

30849884001250

Quantity per Package

50

Contains DI Package

00849884001259

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-