S5 Console

GUDID 04033817902676

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type

• Primary Device ID: 04033817902676
• NIH Device Record Key: e5f5eb5e-6e83-4aaf-ac1c-eb9a6952f9c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S5 Console
• Version Model Number: 4-position
• 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	04033817902676 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210130

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: 2021-05-24
• Device Publish Date: 2021-05-14

On-Brand Devices [S5 Console]

• 04033817902751: S5 Min.I.
• 04033817902683: 5-position
• 04033817902676: 4-position
• 04033817902669: 3-position
• 04033817903123: CP5 Console
• 04033817900900: 5-position
• 04033817900894: 4-position
• 04033817900887: 3-position
• 04033817900535: Ice Container