Catalog Number

AMS-497-1

Brand Name

VYGON

Version/Model Number

AMS-497-1

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

f35e6c69-bbc6-46ac-8cf6-ad5adf1450fb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2016

Package DI Number

38498840010199

Quantity per Package

50

Contains DI Package

08498840010198

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-