Catalog Number

CMS-207

Brand Name

VYGON

Version/Model Number

CMS-207

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

K954302,K954302

Product Code

LJS

Product Code Name

Catheter, intravascular, therapeutic, long-term greater than 30 days

Public Device Record Key

4e37cdbc-661d-4f3f-97a1-451d4e024595

Public Version Date

June 10, 2020

Public Version Number

1

DI Record Publish Date

June 02, 2020

Package DI Number

30849884003940

Quantity per Package

10

Contains DI Package

00849884003949

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-