Michigan Critical Care Consultants, Inc.

GUDID 20854916006397

Soft Flow Aortic Catheter 6MM Angled w. Flange Vented

MICHIGAN CRITICAL CARE CONSULTANTS, INC.

Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial

• Primary Device ID: 20854916006397
• NIH Device Record Key: 229270d3-230c-4465-9095-15b9728e69f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Michigan Critical Care Consultants, Inc.
• Version Model Number: 7080
• 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: false
• 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

Customer Support Contacts

• Phone: 734-995-9089
• Email: mrumford@mc3corp.com
• Phone: 734-995-9089
• Email: mrumford@mc3corp.com
• Phone: 734-995-9089
• Email: mrumford@mc3corp.com
• Phone: 734-995-9089
• Email: mrumford@mc3corp.com
• Phone: 734-995-9089
• Email: mrumford@mc3corp.com
• Phone: 734-995-9089
• Email: mrumford@mc3corp.com
• Phone: 734-995-9089
• Email: mrumford@mc3corp.com
• Phone: 734-995-9089
• Email: mrumford@mc3corp.com
• Phone: 734-995-9089
• Email: mrumford@mc3corp.com
• Phone: 734-995-9089
• Email: mrumford@mc3corp.com
• Phone: 734-995-9089
• Email: mrumford@mc3corp.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10854916006383 [Primary]
GS1	20854916006397 [Package]; Contains: 10854916006383; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132451

FDA Product Code

• DWF: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-08-05
• Device Publish Date: 2016-09-23

On-Brand Devices [Michigan Critical Care Consultants, Inc.]

• 20854916006397: Soft Flow Aortic Catheter 6MM Angled w. Flange Vented
• 10854916006086: Soft Flow Extended Aortic Cannula 24FR/8MM VENTED
• 10854916006062: Soft Flow Extended Aortic Cannula, 24FR, 8MM, NON VENTED
• 10854916006048: Soft Flow Extended Aortic Cannula 21FR 7MM VENTED
• 10854916006024: Soft Flow Extended Aortic Cannula, 21FR, 7MM, NON VENTED