Cook Medical G53177 - TRAY, BLUE RHINO, PERCUTANEOUS, INTRODUCER, EACH

Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Tray

Blue Rhino G2 is a percutaneous tracheostomy introducer that enables full dilatation of the stoma in just one pass. The device''s crosshatch handle helps enhance the operator''s grip to improve procedural control, while longitudinal grooves on the distal surface help facilitate a less forceful insertion. With these unique design features and a comprehensive procedural tray, Blue Rhino G2 provides you with a simple, effective solution for bedside percutaneous dilatational tracheostomy (PDT) procedures.

Intended Use

The Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.

Included Components

The Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Tray consists of these components:

# Ciaglia Blue Rhino G2 Hydrophilic-Coated Percutaneous Tracheostomy Dilator	1	# Double Swivel Connector	1
# 8 Fr Ciaglia Tracheostomy Guiding Catheter	1	# 5 mL Lidocaine	1
# 0.052 inch diameter Wire Guide with Positioning Marks	1	# 30" x 44" Drape	1
# 24 Fr Soft Ciaglia Tracheostomy Loading Dilator	1	# Needle Holder Cup	1
# 26 Fr Soft Ciaglia Tracheostomy Loading Dilator	1	# Safety Scalpel	1
# 28 Fr Soft Ciaglia Tracheostomy Loading Dilator	1	# 2/0 Polypro Blue Monofilament Suture	1
# 14 Fr Dilator, 4.5 cm long	1	# PVP Ointment	1
# 15 gage Catheter Access Needle, 7 cm long	1	# 5 Stainless Steel Curved Hemostat	1
# 15 gage Percutaneous Entry Needle, 5 cm long	1	# ChloraPrep with Tint	1
# 15 gage Percutaneous Entry Needle, 7 cm long	1	# CSR Wrap	1
# 12 mL Syringe	1	# Wire Guide Dispenser	1
# 6 mL Syringes	2	# Filter Straw	1
# Gauze Sponges	10	# 22 gage Needle	1
# 22 gage Needle	1	# 25 gage Needle	1

Cost Difference of PDT vs. Surgical Tracheostomy (ST)

Compared to surgical tracheostomy, bedside PDT performed with the Blue Rhino G2 offers substantial cost savings due to the elimination of high OR expenses and anesthesia fees as well as reduced physician time.

Clinical Speciality

• Critical Care Medicine
• General Surgery
• Otolaryngology
• Pulmonary Medicine

Contraindications

• Emergency tracheostomy tube placement
• Patients with enlarged thyroids
• Nonpalpable cricoid cartilage
• Pediatric applications
• Non-intubated patients
• PEEP (Positive End Expiratory Pressure) value greater than or equal to 20
• Uncorrected coagulopathy
• Pre-existing infection at the tracheostomy site
• Pre-existing malignancy at the tracheostomy site
• Unstable cervical spine fracture
• Previous surgery at the tracheostomy site (e.g., thyroidectomy)

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

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.