Catalog Number

AMS-541

Brand Name

VYGON

Version/Model Number

AMS-541

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

K011336,K011336

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

28c6b675-8a2f-438c-9fe0-c952af895e3e

Public Version Date

November 22, 2019

Public Version Number

1

DI Record Publish Date

November 14, 2019

Package DI Number

30849884000291

Quantity per Package

50

Contains DI Package

00849884000290

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-