FDA.reportPublic FDA data

Novalung System

Primary DI
04057224902043
Brand
Novalung System
Company
XENIOS AG
Model
Novalung console
Catalog number
30000162
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.
Published
2020-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
QJZExtracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJZExtracorporeal System For Long-Term Respiratory / Cardiopulmonary FailureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191407000Novalung SystemFresenius Medical Care Renal Therapies Group, LLC2020-02-21QJZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04057224902043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057224902043040572249020434057224902043

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system centrifugal pump drive unitA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341858364
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04057224103778Novalung Ultimate Kit (U.S.)F320000152026-05-15
04057224001494Novalung SystemXLung kit320000042020-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04057224103778Novalung Ultimate Kit (U.S.)XENIOS AGQJZ2026-05-15
07613336149201VENTANA CLDN18 (43-14A) RxDx AssayVentana Medical Systems, Inc.QJZ2024-12-11
10850007732339VitalFlow SetMICHIGAN CRITICAL CARE CONSULTANTS, INC.QJZ2024-09-19
04057224001494Novalung SystemXENIOS AGQJZ2020-12-17