Bubble Detector

GUDID 04033817900597

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type

• Primary Device ID: 04033817900597
• NIH Device Record Key: ab5d54a3-456d-4d62-8f22-340f0365cba1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bubble Detector
• Version Model Number: Sensor 3/8"
• 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	04033817900597 [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: 2015-10-14

On-Brand Devices [Bubble Detector]

• 04033817902591: Sensor Module
• 04033817900665: Sensor Module
• 04033817900603: Sensor 3/16"
• 04033817900597: Sensor 3/8"
• 04033817900580: Sensor 1/2"
• 04033817900573: Sensor 1/4"