Catalog Number

AMS-530

Brand Name

VYGON

Version/Model Number

AMS-530

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

K101368,K101368

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

e25d5cfb-6375-420a-88d5-22fa4937162e

Public Version Date

September 30, 2019

Public Version Number

1

DI Record Publish Date

September 20, 2019

Package DI Number

38498840012865

Quantity per Package

50

Contains DI Package

08498840012864

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-