Novalung Ultimate Kit (U.S.)

Primary DI
04057224103778
Brand
Novalung Ultimate Kit (U.S.)
Company
XENIOS AG
Model
F32000015
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BYSOxygenator, Long Term Support Greater Than 6 Hours
QJZExtracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
QWFTubing, Long Term Support Greater Than 6 Hours

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYSOxygenator, Long Term Support Greater Than 6 HoursCardiovascular2
QJZExtracorporeal System For Long-Term Respiratory / Cardiopulmonary FailureCardiovascular2
QWFTubing, Long Term Support Greater Than 6 HoursCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232926000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232926000Novalung ultimate kit (US)Fresenius Medical Care Renal Therapies Group, LLC2024-04-15QJZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04057224103778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057224103778040572241037784057224103778

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system blood 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.

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
04057224001494Novalung SystemXLung kit320000042020-12-17
04057224902043Novalung SystemNovalung console300001622020-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10850007732315Nautilus VF ECMO OxygentaorMICHIGAN CRITICAL CARE CONSULTANTS, INC.BYS2024-09-19
10850007732322Nautilus VF Oxygenator CableMICHIGAN CRITICAL CARE CONSULTANTS, INC.BYS2024-09-19
10850007732339VitalFlow SetMICHIGAN CRITICAL CARE CONSULTANTS, INC.QJZ2024-09-19
10854916006895MC3 Nautilus Smart ECMO ModuleMICHIGAN CRITICAL CARE CONSULTANTS, INC.BYS2023-07-03
10854916006901MC3 Nautilus ECMO OxygenatorMICHIGAN CRITICAL CARE CONSULTANTS, INC.BYS2023-07-03
20854916006892MC3 Nautilus Smart ECMO ModuleMICHIGAN CRITICAL CARE CONSULTANTS, INC.BYS2023-07-03
20854916006908MC3 Nautilus ECMO OxygenatorMICHIGAN CRITICAL CARE CONSULTANTS, INC.BYS2023-07-03
10854916006987MC3 Nautilus(tm) Smart Power Supply 12VDCMICHIGAN CRITICAL CARE CONSULTANTS, INC.BYS2023-06-22
04057224001494Novalung SystemXENIOS AGQJZ2020-12-17
04057224902043Novalung SystemXENIOS AGQJZ2020-12-17
10850007732032MC3 Nautilus(tm) Smart Power Supply 12VDCMICHIGAN CRITICAL CARE CONSULTANTS, INC.BYS2020-05-01
10850007732087MC3 Nautilus Power Cord NEMA MICHIGAN CRITICAL CARE CONSULTANTS, INC.BYS2020-05-01
10854916006871MC3 Nautilus (tm) Smart ECMO ModuleMICHIGAN CRITICAL CARE CONSULTANTS, INC.BYS2020-05-01
10854916006888MC3 Nautilus(tm) ECMO OxygenatorMICHIGAN CRITICAL CARE CONSULTANTS, INC.BYS2020-05-01