Accessories

GUDID 04033817903642

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type

• Primary Device ID: 04033817903642
• NIH Device Record Key: 5d761ff1-432c-4e3a-9bb2-63658d0c59a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accessories
• Version Model Number: Control unit arm
• 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	04033817903642 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221373

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: 2023-03-29
• Device Publish Date: 2023-03-21

On-Brand Devices [Accessories]

• 04033817903147: Temperature Probe Inspire
• 04033817903130: Temperature Probe Kids
• 04033817903642: Control unit arm
• 04033817903338: Console Lamp
• 04033817902492: Flow Sensor 1/2“ x 3/32“
• 04033817902485: Flow Sensor 3/8“ x 3/32“
• 04033817902478: Flow Sensor 1/4“ x 1/16“
• 04033817902461: Flow Sensor 3/16“ x 1/16”
• 04033817902454: Bubble Sensor 1/2“ x 3/32“
• 04033817902447: Bubble Sensor 3/8“ x 3/32“
• 04033817902430: Bubble Sensor 1/4“ x 1/16“
• 04033817902423: Bubble Sensor 3/16“ x 1/16”
• 04033817901648: CONSOLE LAMP LED