Catalog Number

AMS-859CS-3

Brand Name

VYGON

Version/Model Number

AMS-859CS-3

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

-

Product Code

LRS

Product Code Name

I.V. start kit

Public Device Record Key

dee08940-f647-4366-ad8e-22a41b20ed1f

Public Version Date

December 11, 2019

Public Version Number

2

DI Record Publish Date

February 19, 2019

Package DI Number

38498840011394

Quantity per Package

50

Contains DI Package

08498840011393

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-