Catalog Number

CLG-2034

Brand Name

VYGON

Version/Model Number

CLG-2034

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

K013871,K013871,K013871

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

ac992543-5530-4af9-8c2a-c3196d3766ff

Public Version Date

April 01, 2020

Public Version Number

1

DI Record Publish Date

March 24, 2020

Package DI Number

50849884003807

Quantity per Package

18

Contains DI Package

30849884003803

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-