Bunnell_Inc._-_Sole_Source_Letter.pdf

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BUNNELL LIFE PULSE VENTILATOR MAINTENANCE
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N0018320Q0001
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Bunnell Sole Source Letter

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436 Lawndale Drive, Salt Lake City, UT 84115 Voice: (800) 800-4358 Ext.117 Fax: (801) 467-0867

E-mail: Matt@bunl.com

November 16, 2018

This letter is provided to attest that Bunnell Incorporated in Salt Lake City, Utah is the only manufacturer and the sole-source distributer of the LifePulse High-Frequency Jet Ventilator and the WhisperJet Patient Box.

Bunnell Inc. is also the sole-source for disposable products used with the “Jet” ventilator, and the sole-source for rentals of the Jet ventilator. Bunnell Inc. is the sole OEM provider for maintenance of the Life Pulse HFV ventilators and patient boxes, no other companies are OEM certified by or through Bunnell.

The LifePulse system is unique in its revolutionary design and advanced treatment of premature infants in acute respiratory failure, an often-fatal complication of preterm birth.

Our ventilators and patented technology have been approved by the U.S. Food and Drug Administration for clinical use since 1988. The LifePulse HFJV is the only FDA approved mode of high frequency jet ventilation that is available in the USA. Hundreds of hospitals in the United States, Canada, Europe, Australia, Malaysia, and Uruguay are using our devices, helping save the lives of approximately 100,000 infants.

Bunnell Incorporated is the only company providing this technology, made possible by the LifePort endotracheal tube adapter. This device allows clinicians to implement treatment more quickly without reintubation, a potentially traumatic procedure for fragile neonates. The clinical application for the LifePulse HFJV allows for unique treatment of infants with respiratory distress syndrome and pulmonary interstitial emphysema, with many advantages over conventional ventilation devices. Respiratory distress syndrome is the leading cause of chronic lung disease, brain injury and death in newborn infants.

For more than 35 years, Bunnell Inc. has been committed to saving babies, with the highest standards of quality, performance and value. Our customer service is elite, providing technical and clinical assistance on our 24-hour hotline, as well as emergency delivery of our devices anywhere in the United States, usually within 2-4 hours of a clinician’s request.

If you would like more clinical or technical information on the LifePulse HFJV system, and why it works like no other ventilator, please visit this page on our website, www.bunl.com.

Thank you for your considering the implementation of the LifePulse HFJV at your hospital. We look forward to working with you in a long and successful partnership.

Matt Winzenried Director of Sales and Marketing Bunnell Inc.

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