FDA.reportPublic FDA data

MC3 Nautilus ECMO Oxygenator

Primary DI
20854916006908
Brand
MC3 Nautilus ECMO Oxygenator
Company
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
Model
48145E
Catalog number
48145E
Device description
Nautilus ECMO oxygenators are diffusion membrane oxygenators 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.
Published
2023-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K191935000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191935000Nautilus Smart ECMO ModuleMc3 Incorporated2020-04-09BYS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20854916006908PackageGS11In Commercial Distribution
10854916006901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085491600690820854916006908
1085491600690110854916006901

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
10850007732315Nautilus VF ECMO Oxygentaor58110581102024-09-19
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

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
10850007732315Nautilus VF ECMO OxygentaorMICHIGAN CRITICAL CARE CONSULTANTS, INC.BYS2024-09-19
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
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