ESSENZ

GUDID 04033817903086

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type

• Primary Device ID: 04033817903086
• NIH Device Record Key: a45c53ad-1c28-4f64-9088-c5325eea6d56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESSENZ
• Version Model Number: RP85
• 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	04033817903086 [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
• 04033817903017: ILBM Sensor Module