MC3 Crescent RA Dual Lumen Catheter 15FR 70415

GUDID 10850007732216

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: 10850007732216
• NIH Device Record Key: 0a239010-1d2a-49bf-b87c-251ab9f95660
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MC3 Crescent RA Dual Lumen Catheter 15FR
• Version Model Number: 70415
• Catalog Number: 70415
• 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	10850007732216 [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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