Heater-Cooler System

GUDID 04033817900511

LivaNova Deutschland GmbH

Cardiopulmonary bypass system heating/cooling unit

• Primary Device ID: 04033817900511
• NIH Device Record Key: 18aa7a3b-bbfe-42a5-9318-237e9a0d994b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heater-Cooler System
• Version Model Number: 3T 208V ~ / 60Hz
• Company DUNS: 343225272
• Company Name: LivaNova Deutschland GmbH
• 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	04033817900511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052601

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: 2015-10-14

On-Brand Devices [Heater-Cooler System]

• 04033817901112: 3T 240V ~ / 60Hz
• 04033817900528: 3T 120V ~ / 60Hz
• 04033817900511: 3T 208V ~ / 60Hz