Cook Medical G36401 - CATHETER, EXCHANGE, SOFT TIP, 11FR, 2.3MM ID, EACH

Cook Medical G36401 – CATHETER, EXCHANGE, SOFT TIP, 11FR, 2.3MM ID, EACH

Cook Airway Exchange Catheter ? Extra-Firm with Soft Tip

The Cook Airway Exchange Catheter is a blunt-tipped radiopaque catheter with centimeter markings to facilitate placement. The catheter is supplied with a Rapi-Fit Adapter (with either a 15 mm connector or a Luer lock connector), permitting use of ventilatory devices during exchange procedure.

Used for uncomplicated, atraumatic endotracheal tube exchange or double-lumen endobronchial tube exchange.

Exchange

Unlike traditional stylets used to facilitate tube exchange, Cooks airway exchange catheters are hollow to permit oxygen delivery if necessary. They are also available in different size options and materials to accommodate varying clinical needs.

Intended for Uncomplicated, Atraumatic Endotracheal Tube Exchange

C-CAE-11.0-100 (inner diameter: 2.3 mm):

For use in replacement of double-lumen endotracheal tubes or endotracheal tubes whose inner diameter (ID) is 4 mm or larger.

Order Number	Reference Part Number	Catheter (Fr)	Catheter Length (cm)	Catheter ID (mm)	For Placement of ETT* with ID (mm)	Includes Adapter Type
G07833	C-CAE-11.0-100-DLT-EF-ST	11.0	100	2.3	4 mm or larger	one 15 mm, one Luer lock

Features and Benefits

• Blunt, soft, flexible tip of catheter is atraumatic to internal structures. Distal 7 cm of catheter is flexible.
• Extra-firm catheter facilitates exchange of double-lumen tubes.
• Distal sideports help ensure sufficient airflow and prevent catheter from whipping during jet ventilation.
• Centimeter markings facilitate accurate placement with endotracheal tubes.
• Removable Rapi-Fit adapter with 15 mm and Luer lock connectors permits use of ventilatory device if necessary during exchange procedure.

Components

• Radiopaque catheter
• Rapi-Fit Adapter (15 mm connector)
• Rapi-Fit Adapter (Luer lock connector)

Clinical Speciality

• Anesthesiology
• Critical Care Medicine
• Emergency Medicine

Potential Adverse Events

• Barotrauma
• Perforation of the bronchi or lung parenchyma

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as “Not made with natural rubber latex”:	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

Instructions for Use (Use of Rapi-Fit Adapter)

A ventilatory device may be used at any time during the endotracheal tube exchange procedure by utilizing the attached Rapi-Fit Adapter.

1. To attach Rapi-Fit Adapter, position the adapter on catheter, then push the white collar forward and lock into position.
   NOTE: Use of a high-pressure oxygen source should only be considered if the patient has sufficient egression of the insufflated gas volume.
2. To remove the adapter, pull the white collar back to release, then remove from catheter.

Warnings

• Attention should be paid to insertion depth of catheter into patients airway and correct tracheal position of replacement endotracheal tube. Markers on the Cook Airway Exchange Catheter refer to distance from tip of catheter. Catheter and endotracheal tube should not be advanced beyond the carina.
• Ensure proper sizing of the Cook Airway Exchange Catheter within a double-lumen endotracheal tube. Failure to do so may cause small fragments to be shaved off during removal of the Cook Airway Exchange Catheter.
• To avoid barotrauma, ensure that the tip of the CAE catheter is always above the carina, preferably 2-3 cm.

Precautions

• The product is intended for use by physicians trained and experienced in airway management techniques. Standard techniques for placement and exchange of endotracheal tubes should be employed.
• This product is not intended for intravascular use.

How Supplied

Supplied sterilized by ethylene oxide gas in peel-open packages. Intended for one-time use. Sterile if package is unopened or undamaged. Do not use the product if there is doubt as to whether the product is sterile. Store in a dark, dry, cool place. Avoid extended exposure to light. Upon removal from package, inspect the product to ensure no damage has occurred.