CardioQuip Modular Cooler-Heater (MCH) - The CardioQuip Modular Cooler-Heater (MCH) is - CARDIOQUIP, LLC

Duns Number:144183733

Device Description: The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled w The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers, and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.

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More Product Details

Catalog Number

-

Brand Name

CardioQuip Modular Cooler-Heater (MCH)

Version/Model Number

MCH-1000(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

K102147

Product Code Details

Product Code

DWC

Product Code Name

Controller, Temperature, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

090efd33-0527-4480-a5c3-5fdb238e9369

Public Version Date

December 16, 2020

Public Version Number

1

DI Record Publish Date

December 08, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARDIOQUIP, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4