MC3 Nautilus(tm) Smart Power Supply 12VDC 48150

GUDID 10850007732032

12V power supply component for the Nautilus(tm) Smart ECMO Module

MICHIGAN CRITICAL CARE CONSULTANTS, INC.

Extracorporeal membrane oxygenator
Primary Device ID10850007732032
NIH Device Record Keycf8b3388-ac86-49b8-8b61-bcb3c5ca065f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMC3 Nautilus(tm) Smart Power Supply 12VDC
Version Model Number48150
Catalog Number48150
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110850007732032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BYSOxygenator, Long Term Support Greater Than 6 Hours

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-11
Device Publish Date2020-05-01

On-Brand Devices [MC3 Nautilus(tm) Smart Power Supply 12VDC]

1085000773203212V power supply component for the Nautilus(tm) Smart ECMO Module
1085491600698712V power supply component for the Nautilus(tm) Smart ECMO Module This is the power supply acce

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