Catalog Number

70105.2902

Brand Name

MAQUET CARDIOHELP

Version/Model Number

CARDIOHELP Country Kit EnglUS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 06, 2017

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

-

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

K133598

Product Code

DTQ

Product Code Name

CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Public Device Record Key

9b131830-1606-4550-a582-56d2a7d54bf1

Public Version Date

June 30, 2020

Public Version Number

4

DI Record Publish Date

November 17, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-