ESSENTIAL PRESCRIBING INFORMATION

CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

INTENDED USE: The Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set is intended to establish emergency airway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing either the percutaneous entry (Seldinger) technique or the surgical technique via the cricothyroid membrane.

CONTRAINDICATIONS: No absolute contraindications known.

RELATIVE CONTRAINDICATIONS: Tracheal transection • Laryngeal fracture • Preexisting laryngeal pathology • Preexisting tracheal pathology • Coagulopathy

WARNINGS: Consideration should be given to the following medical and anatomic conditions and/or therapies: • Unfavorable anatomy (e.g., short neck, morbid obesity and/or aberrant anatomy) • Subcutaneous abscess • Hematoma • Postoperative scarring/radiation • Coagulopathies or systemic thrombolytic therapy • Inflation of the cuff with more than 20 mL is not recommended

PRECAUTIONS: This product is intended for use by clinicians trained and experienced in proper emergency airway techniques. Standard emergency techniques for the placement of a Seldinger or surgical cricothyrotomy should be employed. • Patients in need of cricothyrotomy may have significant spinal injury. In patients who have sustained significant trauma, the cervical spine should be immobilized throughout the procedure, if possible. • Whenever possible and appropriate, utilize aseptic technique and local anesthetic for the procedure. • The potential effects of phthalates on pregnant/nursing women or children have not been fully characterized and there may be concern for reproductive and developmental effects.

POTENTIAL ADVERSE EVENTS: Bleeding • Hematoma • Failed tube placement • Subcutaneous emphysema • Tracheoesophageal fistula • Pneumomediastinum • Pneumothorax • Vocal cord injury • Voice change or dysphonia • Infection • Subglottic/glottic stenosis • Catheter dislodgement

See package insert for full product information.

AB_C_T_UTCCSB2_REV0

ESSENTIAL PRESCRIBING INFORMATION

CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

INTENDED USE: The Melker Cuffed Emergency Cricothyrotomy Catheter Set – Percutaneous is intended to establish emergency airway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing the percutaneous entry (Seldinger) technique via the cricothyroid membrane.

CONTRAINDICATIONS: No absolute contraindications known.

RELATIVE CONTRAINDICATIONS: Tracheal transection • Laryngeal fracture • Preexisting laryngeal pathology • Preexisting tracheal pathology • Coagulopathy

WARNINGS: Consideration should be given to the following medical and anatomic conditions and/or therapies: • Unfavorable anatomy (e.g., short neck, morbid obesity and/or aberrant anatomy) • Subcutaneous abscess • Hematoma • Scarring • Irradiated tissue • Coagulopathies or systemic thrombolytic therapy • Inflation of the cuff with more than 20 mL is not recommended

PRECAUTIONS: This product is intended for use by clinicians trained and experienced in emergency airway management techniques. Standard emergency techniques for the placement of Seldinger airway catheters should be employed. • Patients in need of cricothyrotomy may have significant spinal injury. In patients who have sustained significant trauma, the cervical spine should be immobilized throughout the procedure, if possible. • Whenever possible and appropriate, utilize aseptic technique and local anesthetic for the procedure. • The potential effects of phthalates on pregnant/nursing women or children have not been fully characterized and there may be concern for reproductive and developmental effects.

POTENTIAL ADVERSE EVENTS: Bleeding • Hematoma • Failed tube placement • Subcutaneous emphysema • Tracheoesophageal fistula • Pneumomediastinum • Pneumothorax • Vocal cord injury • Voice change or dysphonia • Infection • Subglottic/glottic stenosis • Catheter dislodgement

See package insert for full product information.

AB_C_T_TCCS2_REV0

ESSENTIAL PRESCRIBING INFORMATION

CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

INTENDED USE: Melker Cuffed and Uncuffed Emergency Cricothyrotomy Catheter Sets are intended to establish emergency airway access when endotracheal intubation cannot be performed. Airway access is achieved using percutaneous entry (Seldinger) technique via the cricothyroid membrane. Subsequent dilation of the tract and tracheal entrance site permits passage of the emergency airway catheter.

CONTRAINDICATIONS: No absolute contraindications known.

WARNINGS: The Melker Cuffed and Uncuffed Emergency Cricothyrotomy Catheter Sets are not specifically designed for pediatric applications. Use with pediatric patients should be determined by attending physician. • Consideration should be given to the following medical and anatomic conditions: – Distorted anatomy – Subcutaneous abscess – Hematoma – Post-operative scarring/radiation – Coagulopathies or systemic thrombolytic therapy

PRECAUTIONS: This product is intended for use by physicians trained and experienced in emergency airway management techniques. Standard techniques for percutaneous placement of airway catheters should be employed. • Patients in need of cricothyrotomy may have significant spinal injury. In patients who have sustained significant trauma, the cervical spine should be immobilized throughout the procedure, if possible. • Whenever possible and appropriate, utilize aseptic technique and local anesthetic for the procedure.

See package insert for full product information.

AB_C_T_TCCS_REV1

ESSENTIAL PRESCRIBING INFORMATION

CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

INTENDED USE: The Melker Cuffed Emergency Cricothyrotomy Catheter Set – Surgical is intended to establish emergency airway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing the surgical technique via the cricothyroid membrane.

CONTRAINDICATIONS: No absolute contraindications known.

RELATIVE CONTRAINDICATIONS : Tracheal transection • Laryngeal fracture • Preexisting laryngeal pathology • Preexisting tracheal pathology • Coagulopathy

WARNINGS: Consideration should be given to the following medical and anatomic conditions and/or therapies: • Unfavorable anatomy (e.g., short neck, morbid obesity and/or aberrant anatomy) • Subcutaneous abscess • Hematoma • Scarring • Irradiated tissue • Coagulopathies or systemic thrombolytic therapy • Inflation of the cuff with more than 20 mL is not recommended

PRECAUTIONS: This product is intended for use by clinicians trained and experienced in proper emergency airway techniques. Standard emergency techniques for a surgical cricothyrotomy should be employed • Patients in need of cricothyrotomy may have significant spinal injury. In patients who have sustained significant trauma, the cervical spine should be immobilized throughout the procedure, if possible. • Whenever possible and appropriate, utilize aseptic technique and local anesthetic for the procedure. • The potential effects of phthalates on pregnant/nursing women or children have not been fully characterized and there may be concern for reproductive and developmental effects.

POTENTIAL ADVERSE EVENTS : : Bleeding • Hematoma • Failed tube placement • Subcutaneous emphysema • Tracheoesophageal fistula • Pneumomediastinum • Pneumothorax • Vocal cord injury • Voice change or dysphonia • Infection • Subglottic/glottic stenosis • Catheter dislodgement

See package insert for full product information.

AB_C_T_MECCCS2_REV0