Catalog Number

6384

Brand Name

MC3

Version/Model Number

6384

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

K132451,K132451,K132451

Product Code

DWF

Product Code Name

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Public Device Record Key

7d9143e8-0197-459d-b2ac-faad2859614f

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

January 10, 2018

Package DI Number

20854916006656

Quantity per Package

10

Contains DI Package

10854916006642

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-