Device

GUDID 04033817904137

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type

• Primary Device ID: 04033817904137
• NIH Device Record Key: 26fefa9d-6c89-4766-9155-e340e4a413a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Device
• Version Model Number: HOLDER WITH MAST-CLAMP LONG
• 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: true
• Serial Number: false
• 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	04033817904137 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232291

FDA Product Code

• DTQ: CONSOLE, HEART-LUNG MACHINE, 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: 2026-01-30
• Device Publish Date: 2026-01-22

On-Brand Devices [Device]

• 04033817904144: COCKPITARM - VARIABLE HEIGHT
• 04033817904137: HOLDER WITH MAST-CLAMP LONG