Catalog Number

AMS-477

Brand Name

VYGON

Version/Model Number

AMS-477

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

fa7ae2d2-4731-43f0-8e4a-4dede7161784

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 04, 2016

Package DI Number

38498840001197

Quantity per Package

50

Contains DI Package

08498840001196

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-