Catalog Number

AMS-427

Brand Name

VYGON

Version/Model Number

AMS-427

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

K894954,K894954

Product Code

FPB

Product Code Name

Filter, infusion line

Public Device Record Key

89c68954-f647-4782-9cc4-e12047f6b4a2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 04, 2016

Package DI Number

38498840001067

Quantity per Package

50

Contains DI Package

08498840001066

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-