CardioQuip Modular Cooler-Heater (MCH)

GUDID 00860000846103

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.

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: 00860000846103
• NIH Device Record Key: 090efd33-0527-4480-a5c3-5fdb238e9369
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioQuip Modular Cooler-Heater (MCH)
• Version Model Number: MCH-1000(i)
• 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	00860000846103 [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

On-Brand Devices [CardioQuip Modular Cooler-Heater (MCH)]

• 00860000846110: The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water t
• 00860000846103: The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water t