Electronic Gas Blender

GUDID 04033817900696

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type

• Primary Device ID: 04033817900696
• NIH Device Record Key: b108bd33-d16d-4baf-b70f-75223de8950a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Electronic Gas Blender
• Version Model Number: 10 l/min
• 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	04033817900696 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080832
• Premarket Notification: K101046

FDA Product Code

• DTQ: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• DTX: Gas control unit, 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: 4
• Public Version Date: 2024-05-07
• Device Publish Date: 2015-10-16

On-Brand Devices [Electronic Gas Blender]

• 04033817900719: 2 l/min
• 04033817900702: 5 l/min
• 04033817900696: 10 l/min