MC3 Crescent RA Dual Lumen Catheter 13FR 70413

GUDID 10850007732209

The Jugular Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in adult and pediatric patients with acute respiratory failure requiring VenoVenous Extracorporeal Membrane Oxygenation where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

MICHIGAN CRITICAL CARE CONSULTANTS, INC.

Mobile extracorporeal gas exchange system catheter kit

• Primary Device ID: 10850007732209
• NIH Device Record Key: 6ea43a10-349c-4fd7-9621-a625b68d7e98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MC3 Crescent RA Dual Lumen Catheter 13FR
• Version Model Number: 70413
• Catalog Number: 70413
• 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	10850007732209 [Primary]

FDA Product Code

• PZS: Dual Lumen Ecmo Cannula

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: 2021-09-09
• Device Publish Date: 2021-09-01

Devices Manufactured by MICHIGAN CRITICAL CARE CONSULTANTS, INC.

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• 10850007732247 - VitalFlow Console: 2024-09-27 Controller for VitalFlow Centrifugal Pump. The VitalFlow Console powers the VitalFlow motor drive unit which provides rotation
• 10850007732254 - VitalFlow Motor Drive: 2024-09-27 Motor drive for the VitalFlow Centrifugal Pump
• 10850007732261 - VitalFlow Emergency Handcrank: 2024-09-27 Emergency handcrank for the VitalFlow Centrifugal Pump
• 10850007732278 - VitalFlow Flow and Bubble Sensor, 2m: 2024-09-27 Flow and Bubble Sensor (2m) for VitalFlow Console
• 10850007732285 - VitalFlow Power Cord NEMA-5-15, 3m: 2024-09-27 AC Power Cord (US Type A, NEMA-5-15, 3m) for VitalFlow Console
• 10850007732292 - VitalFlow Power Cord CEE 7/7, 2.5m: 2024-09-27 AC Power Cord (EU Type F, CEE 7/7, 2.5m) for VitalFlow Console
• 10850007732308 - VitalFlow Power Cord 12 V DC, 3m: 2024-09-27 DC Power Cord (12 V DC, 3m) for VitalFlow Console