Catalog Number

AMS-827CP-1

Brand Name

VYGON

Version/Model Number

AMS-827CP-1

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

af3038dd-7ef2-49dd-8005-11feb79c2c46

Public Version Date

March 27, 2020

Public Version Number

1

DI Record Publish Date

March 19, 2020

Package DI Number

30849884004473

Quantity per Package

50

Contains DI Package

00849884004472

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-