Catalog Number

CMS-8000

Brand Name

VYGON

Version/Model Number

CMS-8000

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

K070705,K070705

Product Code

FOZ

Product Code Name

Catheter, intravascular, therapeutic, short-term less than 30 days

Public Device Record Key

3bdb8a77-2722-4fa4-b109-9503ff4759cc

Public Version Date

May 19, 2020

Public Version Number

2

DI Record Publish Date

January 28, 2020

Package DI Number

30849884001908

Quantity per Package

100

Contains DI Package

00849884001907

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-