ESSENZ

GUDID 04033817903277

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 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: 04033817903277
• NIH Device Record Key: 61105112-0c10-4a68-a2e4-d5e8f60d6912
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESSENZ
• Version Model Number: Flow Module
• 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	04033817903277 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221373

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: 2023-03-29
• Device Publish Date: 2023-03-21

On-Brand Devices [ESSENZ]

• 04033817903178: Perfusion System Monitor
• 04033817903161: Patient Monitor Software
• 04033817903321: Mains/Interface-Box
• 04033817903307: Level Module
• 04033817903291: Temperature Module
• 04033817903284: Pressure Module
• 04033817903277: Flow Module
• 04033817903260: Bubble Module
• 04033817903154: CPED
• 04033817903116: Arterial Clamp- AC arm long (620 mm)
• 04033817903109: Arterial Clamp - AC arm short (500mm)
• 04033817903093: Venous clamp
• 04033817903086: RP85
• 04033817903079: Control Unit
• 04033817903062: HLM
• 04033817903055: Power Pack
• 04033817903048: Cockpit
• 04033817903031: CPD
• 04033817903024: BCP
• 04033817902997: RP150