Variolock

GUDID 04033817901563

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type

• Primary Device ID: 04033817901563
• NIH Device Record Key: 3eb26c2e-2f31-4e9f-a506-5e999418473c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Variolock
• Version Model Number: Inserts Cardioplegia 1:4
• 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: false
• 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	04033817901563 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071318

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: 2016-03-23

On-Brand Devices [Variolock]

• 04033817901976: Insert Cardioplegia 1:1
• 04033817901563: Inserts Cardioplegia 1:4
• 04033817900399: Tubing Clamp RP150
• 04033817900238: Inserts Cardioplegia 4:1
• 04033817900221: Inserts Cardioplegia 4:1
• 04033817900214: Inserts Cardioplegia 2:1
• 04033817900207: Inserts Cardioplegia 1:1
• 04033817900191: Inserts Small
• 04033817900184: Inserts Large