Level Control

GUDID 34033817900628

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type

• Primary Device ID: 34033817900628
• NIH Device Record Key: 5cfe6954-7870-4e26-ba6a-c387d64f68e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Level Control
• Version Model Number: Pads White
• Company DUNS: 343225272
• Company Name: LivaNova Deutschland GmbH
• Device Count: 100
• 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: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	04033817900627 [Unit of Use]
GS1	34033817900628 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-20

On-Brand Devices [Level Control]

• 34033817900635: Pads Green
• 34033817900628: Pads White
• 04033817902386: Sensor
• 04033817902379: Sensor Modul