Novalung System

Primary DI
04057224001494
Brand
Novalung System
Company
XENIOS AG
Model
XLung kit
Catalog number
32000004
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
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
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
04057224001494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057224001494040572240014944057224001494

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system tubing setA collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341858364
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04057224103778Novalung Ultimate Kit (U.S.)F320000152026-05-15
04057224902043Novalung SystemNovalung console300001622020-12-17

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
04057224902043Novalung SystemXENIOS AGQJZ2020-12-17