Catalog Number

4950

Brand Name

MC3

Version/Model Number

4950

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K132811,K132811,K132811

Product Code

DWF

Product Code Name

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Public Device Record Key

5ff103d9-85db-4f6a-82fe-2b3e86b337e1

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

January 10, 2018

Package DI Number

20854916006458

Quantity per Package

10

Contains DI Package

10854916006444

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-