MC3 Nautilus Power Cord NEMA 48155

GUDID 10850007732087

Power Cord (NEMA 5-5, 5m) for Nautilus Smart ECMO Module

MICHIGAN CRITICAL CARE CONSULTANTS, INC.

Extracorporeal membrane oxygenator

• Primary Device ID: 10850007732087
• NIH Device Record Key: c54bc0ca-8c1f-4ab6-a328-0784003cce40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MC3 Nautilus Power Cord NEMA
• Version Model Number: 48155
• Catalog Number: 48155
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10850007732087 [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: 2020-05-11
• Device Publish Date: 2020-05-01

Devices Manufactured by MICHIGAN CRITICAL CARE CONSULTANTS, INC.

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• 20854916006908 - MC3 Nautilus ECMO Oxygenator: 2023-07-11 Nautilus ECMO oxygenators are diffusion membrane oxygenators used in extracorporeal life support procedures to oxygenate blood,
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