MAQUET CARDIOHELP - The CARDIOHELP System is a blood oxygenation and - Maquet Cardiopulmonary AG

Duns Number:316153865

Device Description: The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pum The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit forcirculatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).The CARDIOHELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospitalenvironment (for periods up to six hours), e.g. for intra- and inter-Hospital transport.The CARDIOHELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up to six hours).

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More Product Details

Catalog Number

70107.2780

Brand Name

MAQUET CARDIOHELP

Version/Model Number

CARDIOHELP-i

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DTQ

Product Code Name

CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Device Record Status

Public Device Record Key

aad2ac39-8aa0-4bc5-abfc-c48725cdc659

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 01, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MAQUET CARDIOPULMONARY AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 286