EVO

GUDID 04033817902799

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type

• Primary Device ID: 04033817902799
• NIH Device Record Key: b4d0308c-78a9-4b3e-a946-01ae2ce9ea29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVO
• Version Model Number: Control Unit
• 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	04033817902799 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082344

FDA Product Code

• DWF: Catheter, cannula and tubing, vascular, 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: 2021-05-24
• Device Publish Date: 2021-05-14

Devices Manufactured by LivaNova Deutschland GmbH

• 04033817902423 - Accessories: 2023-03-29
• 04033817902430 - Accessories: 2023-03-29
• 04033817902447 - Accessories: 2023-03-29
• 04033817902454 - Accessories: 2023-03-29
• 04033817902461 - Accessories: 2023-03-29
• 04033817902478 - Accessories: 2023-03-29
• 04033817902485 - Accessories: 2023-03-29
• 04033817902492 - Accessories: 2023-03-29