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510(k) Data Aggregation
K Number
K240114Device Name
UltraEzAir® (UEA1A)
Manufacturer
DUALAMS, Inc., dba AirKor
Date Cleared
2024-10-16
(274 days)
Product Code
CCT
Regulation Number
868.5170Why did this record match?
Applicant Name (Manufacturer) :
DUALAMS, Inc., dba AirKor
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UltraEzAir® is a topical anesthesia applicator used to apply topical anesthetic to a patient's oropharynx and upper airway region through the working channel of a flexible nasal laryngoscope using air flow. The device is designed for and intended to be used by physicians trained and experienced in flexible endoscopic techniques for elective outpatient procedures.
The safety and effectiveness of this device for use in the performance of topical anesthesia of the lower airways (below the level of the trachea) have not been established.
Device Description
The UltraEzAir® is a prescription medical device intended for application of nebulized 4% topical lidocaine solution to the oropharynx and upper airway region of patients. The subject device is an electrically driven device. The subject device is intended to be used only in an outpatient clinical facility or office for anesthetic procedures by a healthcare professional who is trained by Airkor® on its use.
The UltraEzAir® is intended to be used on adult patients, weighing at least 80 lbs. requiring topical anesthesia of oropharynx and upper airway region prior to endoscopic examination in an outpatient clinical facility or office.
The UltraEzAir® consists of a reusable Base, a single-use non-sterile Mist Assembly placed on the Base, and a single-use nonsterile Delivery Line connected to the Mist Assembly. The Delivery Line is then connected to the working channel of an Olympus or Pentax flexible nasal laryngoscope and the lidocaine mist is applied using the distal end of the attached laryngoscope to adjacent target tissue. The application process is visualized using the attached laryngoscope.
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