CardioQuip Refrigeration Module

GUDID 00860000846127

The CardioQuip Refrigeration Module is a module of the CardioQuip Modular Cooler-Heater (MCH) which creates an ice block in the tank in order to lower the temperature of the water. The 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.

CARDIOQUIP, LLC

Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit

• Primary Device ID: 00860000846127
• NIH Device Record Key: 8ace2df6-780d-4db4-a118-324056437145
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioQuip Refrigeration Module
• Version Model Number: MCH-10RMS
• Company DUNS: 144183733
• Company Name: CARDIOQUIP, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000846127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102147

FDA Product Code

• DWC: Controller, Temperature, Cardiopulmonary Bypass

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-16
• Device Publish Date: 2020-12-08

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