CATHETER LS96010-013 BIO-MED ART 13FR

CATHETER LS96010
Bio-Medicus Life Support™ - LS96010-013

A semi-rigid or rigid tube intended to be surgically inserted into an artery or vein to serve as a channel for the extracorporeal transport of oxygenated blood to a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation; in some settings it may be referred to as an arterial cannula. It is typically inserted using a compatible trocar blade which may be included. This is a single-use device.

• Catheter Length: 11.0 Centimeter
• Catheter Gauge: 13.0 French

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QHW

Device Name: Single Lumen Ecmo Cannula

Device Class: 2

Physical State: A polymeric tube designed to fit the anatomy of several different arteries and/or veins for access to the circulatory system

Definition: Single-lumen cannulas/catheters to be used with an extracorporeal circuit intended for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Acts as a conduit for blood flow between the patient's circulatory system and the extracorporeal circuit.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Major arteries/veins leading to/from the heart; some peripheral sites such as jugular or femoral.

Regulation Number: 870.4100

Third Party Flag: N

Medical Specialty: CV

Device Id: 00763000615352

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A