Catalog Number

AMS-894ML

Brand Name

VYGON

Version/Model Number

AMS-894ML

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

K882503,K882503

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

572b6a55-c1f9-4d7b-94a0-6bf358b9629d

Public Version Date

November 11, 2019

Public Version Number

1

DI Record Publish Date

November 01, 2019

Package DI Number

30849884003315

Quantity per Package

50

Contains DI Package

00849884003314

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-