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MC3 Crescent RA Dual Lumen Catheter 15FR

FDA UDI

Class II (US FDA UDI)

by Michigan Critical Care Consultants, Inc.

Identity

Trade Name
MC3 Crescent RA Dual Lumen Catheter 15FR FDA UDI
Generic Name
Mobile extracorporeal gas exchange system catheter kit FDA UDI
Device Name
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. FDA UDI
Model / Reference
70415 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
70415 FDA UDI
Primary DI / UDI-DI
10850007732520 FDA UDI
FDA Product Code
PZS FDA UDI
GMDN Term
Mobile extracorporeal gas exchange system catheter kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Mobile extracorporeal gas exchange system catheter kit

MC3 Crescent RA Dual Lumen Catheter 15FR by Michigan Critical Care Consultants, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mobile extracorporeal gas exchange system catheter kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Michigan Critical Care Consultants, Inc.

Sources (1)

  • FDA UDI e84e0db4-df79-46bf-a949-7977980e4386 34 fields · synced Jun 8, 2026