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

• 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