ESSENZ

GUDID 04033817903161

LivaNova Deutschland GmbH

Patient health record information system

• Primary Device ID: 04033817903161
• NIH Device Record Key: ea70fdc2-6d59-46d5-94d8-4a7e3c601001
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESSENZ
• Version Model Number: Patient Monitor Software
• 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: false
• 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	04033817903161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212003

FDA Product Code

• DXJ: DISPLAY, CATHODE-RAY TUBE, MEDICAL

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: 2022-03-04
• Device Publish Date: 2022-02-24

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