Novalung System

Basic Information

• Brand Name: Novalung System
• Primary DI: 04057224902043
• Version / Model: Novalung console
• Catalog Number: 30000162
• Company Name: XENIOS AG
• Labeler DUNS: 341858364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-17
• Public Version: 1
• Public Version Date: 2020-12-25
• Public Version Status: New
• Public Device Record Key: 1c584ccd-bdb4-4ae5-90e6-a605d413a965

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QJZ	Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure	Cardiovascular	870.4100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33317	Cardiopulmonary bypass system centrifugal pump drive unit	A mains electricity (AC-powered) device that powers and controls the speed of a disposable cardiovascular bypass system centrifugal pump, to which it is connected, for the circulation of blood through the extracorporeal circuit for gas exchange and reinfusion. This device drives the centrifugal rotor of the disposable centrifugal pump using magnetism.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04057224902043	GS1

Premarket Submissions

Submission Number	Supplement Number
K191407	000