MC3 Nautilus ECMO Oxygenator 48145E

GUDID 20854916006908

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.

MICHIGAN CRITICAL CARE CONSULTANTS, INC.

Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator
Primary Device ID20854916006908
NIH Device Record Keycadd0bdd-4770-4ac5-a7ac-736af2109633
Commercial Distribution StatusIn Commercial Distribution
Brand NameMC3 Nautilus ECMO Oxygenator
Version Model Number48145E
Catalog Number48145E
Company DUNS806687406
Company NameMICHIGAN CRITICAL CARE CONSULTANTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110854916006901 [Primary]
GS120854916006908 [Package]
Contains: 10854916006901
Package: Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BYSOxygenator, Long Term Support Greater Than 6 Hours

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-11
Device Publish Date2023-07-03

Devices Manufactured by MICHIGAN CRITICAL CARE CONSULTANTS, INC.

20854916006892 - MC3 Nautilus Smart ECMO Module2023-07-11 Nautilus ECMO oxygenators are diffusion membrane oxygenators used in extracorporeal life support procedures to oxygenate blood,
20854916006908 - MC3 Nautilus ECMO Oxygenator2023-07-11Nautilus 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.
20854916006908 - MC3 Nautilus ECMO Oxygenator2023-07-11 Nautilus ECMO oxygenators are diffusion membrane oxygenators used in extracorporeal life support procedures to oxygenate blood,
10854916006987 - MC3 Nautilus(tm) Smart Power Supply 12VDC2023-06-30 12V power supply component for the Nautilus(tm) Smart ECMO Module This is the power supply accessory for 48135/48135E Nautilus
10854916006024 - Michigan Critical Care Consultants, Inc.2022-08-05 Soft Flow Extended Aortic Cannula, 21FR, 7MM, NON VENTED
10854916006048 - Michigan Critical Care Consultants, Inc.2022-08-05 Soft Flow Extended Aortic Cannula 21FR 7MM VENTED
10854916006062 - Michigan Critical Care Consultants, inc.2022-08-05 Soft Flow Extended Aortic Cannula, 24FR, 8MM, NON VENTED
10854916006086 - Michigan Critical Care Consultants, Inc.2022-08-05 Soft Flow Extended Aortic Cannula 24FR/8MM VENTED
20854916006397 - Michigan Critical Care Consultants, Inc.2022-08-05 Soft Flow Aortic Catheter 6MM Angled w. Flange Vented

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