MC3 Nautilus Smart ECMO Module 48135E

GUDID 20854916006892

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. Smart ECMO Module device contains integrated sensors with an electronic touch screen display. The following measured parameters are visible on the electronic display: inlet pressure, inlet oxygen saturation, outlet pressure, outlet oxygen saturation, and outlet blood temperature.

MICHIGAN CRITICAL CARE CONSULTANTS, INC.

Extracorporeal membrane oxygenator

• Primary Device ID: 20854916006892
• NIH Device Record Key: 97f4f158-d3af-4294-82de-efdd15ba5eaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MC3 Nautilus Smart ECMO Module
• Version Model Number: 48135E
• Catalog Number: 48135E
• Company DUNS: 806687406
• Company Name: MICHIGAN CRITICAL CARE CONSULTANTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10854916006895 [Primary]
GS1	20854916006892 [Package]; Contains: 10854916006895; Package: [1 Units]; In Commercial Distribution

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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-11
• Device Publish Date: 2023-07-03

Devices Manufactured by MICHIGAN CRITICAL CARE CONSULTANTS, INC.

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