Catalog Number

70124

Brand Name

MC3 Crescent Jugular Dual Lumen Catheter

Version/Model Number

70124

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

-

Product Code

PZS

Product Code Name

Dual Lumen Ecmo Cannula

Public Device Record Key

04eb5dcc-05ac-43f8-8c4b-078b4b134aa4

Public Version Date

October 21, 2019

Public Version Number

2

DI Record Publish Date

July 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-