MC3 Nautilus(tm) Smart Power Supply 12VDC 48150

GUDID 10854916006987

12V power supply component for the Nautilus(tm) Smart ECMO Module This is the power supply accessory for 48135/48135E Nautilus Smart ECMO Module

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 Extracorporeal membrane oxygenator

• Primary Device ID: 10854916006987
• NIH Device Record Key: 2f594e60-2b1c-4a31-b082-aeccf1c7db13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MC3 Nautilus(tm) Smart Power Supply 12VDC
• Version Model Number: 48150
• Catalog Number: 48150
• Company DUNS: 806687406
• Company Name: MICHIGAN CRITICAL CARE CONSULTANTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10854916006987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191935

FDA Product Code

• BYS: Oxygenator, Long Term Support Greater Than 6 Hours

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-30
• Device Publish Date: 2023-06-22

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

• 10850007732032: 12V power supply component for the Nautilus(tm) Smart ECMO Module
• 10854916006987: 12V power supply component for the Nautilus(tm) Smart ECMO Module This is the power supply acce