E/P Pack

GUDID 04033817901426

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type

• Primary Device ID: 04033817901426
• NIH Device Record Key: d21dafed-7b98-4831-99f7-8092fa0bee00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E/P Pack
• Version Model Number: C5
• 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	04033817901426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093882

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-05-07
• Device Publish Date: 2015-10-20

On-Brand Devices [E/P Pack]

• 04033817902706: UPS Module
• 04033817902690: S5
• 04033817901426: C5
• 04033817901259: UPS Module
• 04033817901242: DC/DC Module
• 04033817900849: Battery Discharger
• 04033817900832: S5