Nautilus VF ECMO Oxygentaor

Primary DI
10850007732315
Brand
Nautilus VF ECMO Oxygentaor
Company
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
Model
58110
Catalog number
58110
Device description
The Nautilus VF ECMO Oxygenator is a diffusion polymethylpentene (PMP) membrane oxygenator with BalanceTM Biosurface used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Blood enters the device and passes through both the heat exchange membrane, where temperature is adjusted, and the gas transfer membrane, where oxygen is added and carbon dioxide is removed. The device contains integrated sensors. The following measured parameters can be transmitted to the VitalFlow ECMO Console through the Nautilus VF Oxygenator Cable: inlet pressure, inlet oxygen saturation, outlet pressure, outlet oxygen saturation, and outlet blood temperature. The difference between the inlet and outlet pressure, delta pressure, is calculated and also transmitted.
Published
2024-09-19
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYSOxygenator, Long Term Support Greater Than 6 HoursCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232767000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232767000Nautilus VF ECMO OxygenatorMc3, Inc.2023-10-04BYS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850007732315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085000773231510850007732315

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal membrane oxygenatorA device designed for the extracorporeal diffusion of oxygen into blood across a gas-permeable membrane during a cardiopulmonary bypass or extracorporeal membrane oxygenation procedure. It includes a membrane that separates a thin layer of blood from the oxygenating gas; oxygen diffuses from the gas compartment into the blood, while carbon dioxide diffuses from the blood through the membrane and is flushed out of the oxygenator by the oxygen flow. The device may include an integrated heat exchanger, arterial filter, or cardiotomy/venous reservoir. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806687406
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850007732247VitalFlow Console58100581002024-09-19
10850007732421Nautilus VF Oxygenator Cable581302025-07-24
10850007732513MC3 Crescent RA Dual Lumen Catheter 13FR70413704132025-04-16
10850007732520MC3 Crescent RA Dual Lumen Catheter 15FR70415704152025-04-16
10850007732537MC3 Crescent RA Dual Lumen Catheter 19FR70419704192025-04-16
10850007732346VitalFlow Centrifugal Pump 58111581112024-09-20
10850007732254VitalFlow Motor Drive58102581022024-09-19
10850007732261VitalFlow Emergency Handcrank58103581032024-09-19
10850007732278VitalFlow Flow and Bubble Sensor, 2m58150581502024-09-19
10850007732285VitalFlow Power Cord NEMA-5-15, 3m58131581312024-09-19
10850007732292VitalFlow Power Cord CEE 7/7, 2.5m58132581322024-09-19
10850007732308VitalFlow Power Cord 12 V DC, 3m58141581412024-09-19
10850007732322Nautilus VF Oxygenator Cable58130481502024-09-19
10850007732339VitalFlow Set58112581122024-09-19
10850007732353VitalFlow Caddy58120581202024-09-19
10854916006406MC3494849482018-01-10
10854916006420MC3494949492018-01-10
10854916006444MC3495049502018-01-10
10854916006482MC3576157612018-01-10
10854916006505MC3576257622018-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04057224103778Novalung Ultimate Kit (U.S.)XENIOS AGBYS2026-05-15
10850007732421Nautilus VF Oxygenator CableMICHIGAN CRITICAL CARE CONSULTANTS, INC.BYS2025-07-24
10850007732322Nautilus VF Oxygenator CableMICHIGAN CRITICAL CARE CONSULTANTS, INC.BYS2024-09-19
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
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