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

• Primary Device ID: 20854916006908
• NIH Device Record Key: cadd0bdd-4770-4ac5-a7ac-736af2109633
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MC3 Nautilus ECMO Oxygenator
• Version Model Number: 48145E
• Catalog Number: 48145E
• 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: 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	10854916006901 [Primary]
GS1	20854916006908 [Package]; Contains: 10854916006901; Package: Box [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

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