MC3 4950

GUDID 20854916006458

Soft Flow Extended 24 FR 8MM NON 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: 20854916006458
• NIH Device Record Key: 5ff103d9-85db-4f6a-82fe-2b3e86b337e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MC3
• Version Model Number: 4950
• Catalog Number: 4950
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10854916006062 [Previous]
GS1	10854916006444 [Primary]
GS1	20854916006458 [Package]; Contains: 10854916006444; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132811

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: 2018-01-10

On-Brand Devices [MC3]

• 10854916006383: Soft Flow Aortic 18FR 6MM ANGLED FLANGE VENTED
• 10854916006369: Soft Flow Aortic 18FR 6MM ANGLED BULB VENTED
• 10854916006345: Soft Flow Aortic 18FR 6MM ANGLED BULB NON VENTED
• 10854916006321: Soft Flow Aortic 21FR 7MM ANGLED FLANGE VENTED
• 10854916006307: Soft Flow Aortic 21FR 7MM ANGLED FLANGE NON VENTED
• 10854916006284: Soft Flow Aortic 24FR 8MM ANGLED FLANGE VENTED
• 10854916006260: Soft Flow Aortic 24FR 8MM ANGLED FLANGE NON VENTED
• 10854916006246: Soft Flow Aortic 24 FR 8MM STRAIGHT BULB NON VENTED
• 10854916006222: Soft Flow Aortic 21 FR 7MM STRAIGHT BULB NON VENTED
• 10854916006208: Soft Flow Aortic 24 FR 8MM STRAIGHT BULB VENTED
• 10854916006185: Soft Flow Aortic 21 FR 7MM STRAIGHT BULB VENTED
• 10854916006161: Soft Flow Aortic 24FR 8MM ANGLED BULB NON VENTED
• 10854916006147: Soft Flow Aortic 21FR 7MM ANGLED BULB NON VENTED
• 10854916006123: Soft Flow Aortic 24FR 8MM ANGLED BULB VENTED
• 10854916006109: Soft Flow Aortic 21FR 7MM ANGLED BULB VENTED
• 10854916006468: Soft Flow Extended 24 FR 8MM VENTED
• 20854916006458: Soft Flow Extended 24 FR 8MM NON VENTED
• 20854916006434: Soft Flow Extended 21 FR 7MM VENTED
• 20854916006410: Soft Flow Extended 21 FR 7 MM NON VENTED