Heater-Cooler System

Basic Information

• Brand Name: Heater-Cooler System
• Primary DI: 04033817901112
• Version / Model: 3T 240V ~ / 60Hz
• Company Name: LivaNova Deutschland GmbH
• Labeler DUNS: 343225272
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-20
• Public Version: 5
• Public Version Date: 2019-12-23
• Public Version Status: Update
• Public Device Record Key: 807b7ca4-925d-4125-9f89-5fe8643389cd

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWC	Controller, temperature, cardiopulmonary bypass	Cardiovascular	870.4250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17206	Cardiopulmonary bypass system heating/cooling unit	A mains electricity (AC-powered) component of a cardiopulmonary bypass system designed to heat or cool a patient's body by extracorporeal heat exchange with the patient's perfused blood during a cardiopulmonary bypass procedure. It consists of a system to heat or cool a thermal transfer fluid, pumps to provide circulation of the fluid to a heat exchanger, and monitoring and alarm systems. It may be known as a hypothermia/hyperthermia unit because of its ability to regulate body temperature either way.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04033817901112	GS1

Premarket Submissions

Submission Number	Supplement Number
K052601	000