Sarns™ Temperature Control Module 4415

GUDID 00886799000014

TCM II Cooling/Heating System

Terumo Cardiovascular Systems Corporation

Cardiopulmonary bypass system heating/cooling unit

• Primary Device ID: 00886799000014
• NIH Device Record Key: 35ef4f3f-c498-40b8-a275-dc9a6bbb71a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sarns™ Temperature Control Module
• Version Model Number: 4415
• Catalog Number: 4415
• Company DUNS: 177655466
• Company Name: Terumo Cardiovascular Systems Corporation
• 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: true
• 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	00886799000014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K883603

FDA Product Code

• DWC: Controller, Temperature, Cardiopulmonary Bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-23
• Device Publish Date: 2015-09-24

On-Brand Devices [Sarns™ Temperature Control Module]

• 00886799001769: Water fitting, quick-connect for use with oxygenation systems, straight
• 00886799001752: Water fitting, quick-connect for use with oxygenation systems, right angle
• 00886799001745: Water fitting, quick-connect for use with myocardial protection systems
• 00886799000168: TCM II Remote Control Module with Temperature Displays
• 00886799000014: TCM II Cooling/Heating System