Novalung System 30000162

GUDID 04057224902043

The Novalung System, consisting of the Novalung console and XLung kit, is a blood oxygenation and carbon dioxide removal system designed to provide extracorporeal cardiac and/or pulmonary support.

XENIOS AG

Cardiopulmonary bypass system centrifugal pump drive unit

• Primary Device ID: 04057224902043
• NIH Device Record Key: 1c584ccd-bdb4-4ae5-90e6-a605d413a965
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novalung System
• Version Model Number: Novalung console
• Catalog Number: 30000162
• Company DUNS: 341858364
• Company Name: XENIOS AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	04057224902043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191407

FDA Product Code

• QJZ: Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure

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: 2020-12-25
• Device Publish Date: 2020-12-17

On-Brand Devices [Novalung System]

• 04057224902043: The Novalung System, consisting of the Novalung console and XLung kit, is a blood oxygenation an
• 04057224001494: The Novalung System, consisting of the Novalung console and XLung kit, is a blood oxygenation an