Air Purge Control (APC)

GUDID 04033817902638

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type

• Primary Device ID: 04033817902638
• NIH Device Record Key: 8e6223a6-7031-49c9-9d12-cb6fb7341075
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Air Purge Control (APC)
• Version Model Number: Sensor Module
• 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	04033817902638 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091007

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: 2021-05-24
• Device Publish Date: 2021-05-14

On-Brand Devices [Air Purge Control (APC)]

• 04033817902638: Sensor Module
• 04033817901211: Sensor Module