MC3 Opus(tm) Vascular Access Kit 21030

GUDID 10854916006833

Vascular Access Kit

MICHIGAN CRITICAL CARE CONSULTANTS, INC.

Mobile extracorporeal gas exchange system catheter kit

• Primary Device ID: 10854916006833
• NIH Device Record Key: 3fe0e9d5-3dcb-41c4-968b-07112541d85e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MC3 Opus(tm) Vascular Access Kit
• Version Model Number: 21030
• Catalog Number: 21030
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10854916006833 [Primary]
GS1	20854916006847 [Package]; Package: box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182914

FDA Product Code

• DRE: Dilator, Vessel, For Percutaneous Catheterization

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: 2019-06-07
• Device Publish Date: 2019-05-30

Devices Manufactured by MICHIGAN CRITICAL CARE CONSULTANTS, INC.

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• 10854916006048 - Michigan Critical Care Consultants, Inc.: 2022-08-05 Soft Flow Extended Aortic Cannula 21FR 7MM VENTED
• 10854916006062 - Michigan Critical Care Consultants, inc.: 2022-08-05 Soft Flow Extended Aortic Cannula, 24FR, 8MM, NON VENTED
• 10854916006086 - Michigan Critical Care Consultants, Inc.: 2022-08-05 Soft Flow Extended Aortic Cannula 24FR/8MM VENTED
• 20854916006397 - Michigan Critical Care Consultants, Inc.: 2022-08-05 Soft Flow Aortic Catheter 6MM Angled w. Flange Vented