B-Care5

GUDID 04033817900726

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type

• Primary Device ID: 04033817900726
• NIH Device Record Key: f77154b1-6bb1-48b3-896d-3e6d82090070
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B-Care5
• Version Model Number: Sensor Module (venous)
• 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	04033817900726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092463

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: 2015-10-16

On-Brand Devices [B-Care5]

• 04033817901075: Venous Sensor (complete)
• 04033817900726: Sensor Module (venous)