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The HeroTracker Sense Device (HTS) is an add-on device which is attached by patients on a metered-dose inhaler (MDI). HTS is intended for single-patient multiple use in the home environment as an electronic data capture accessory for monitoring and recording actuation, inhaler shake, inhaler orientation, inhalation coordination, and inspiratory strength and duration for prescribed inhaler usage. HTS may be used in the following applications: in clinical practice or clinical trials, where specialists, general practitioners, nurses and educators need to know if a patient has used their prescribed medication or assess inhaler technique. HTS is designed to work only with the MDI and medication indicated on the HTS label. HTS is not intended to indicate the remaining quantity of medication in an inhaler and does not include a dose counting function. HTS is not intended to provide spirometry measurements. HTS is intended to be used by Metered Dose Inhaler (MDI) users aged 12 years and over.

The HeroTracker Sense (HTS) is a nebulizer accessory. It is an add-on device which is attached by patients on a metered dose inhaler (MDI) and is used to record and analyze data related to medication actuation and technique of use for prescribed inhaler usage. Data is transferred to a mobile application with appropriate settings and is displayed to end users.

The AdheResp Smart Breath-actuated Mesh Nebulizer is a system to aerosolize liquid medications for inhalation for patients ranging from pediatrics equal to or greater than 5 years old to adults who can coordinate breathing. The environment of use are Hospital/institutional settings, home care use, schools, and long-term care facilities.

The AdheResp Smart Breath-actuated Mesh Nebulizer consists of a main unit, medication reservoir, mouthpiece, key tag and charging cable, or power adapter. The medication reservoir could be further separated into a medication container and an aerosol chamber. Principle of Operation: There are two key features in the AdheResp Smart Breath-actuated Mesh Nebulizer, which are vibrating mesh nebulization and breath-actuation functions. The AdheResp Smart Breath-actuated Mesh Nebulizer is an active mesh nebulizer. Active mesh nebulizers operate by electrically activating a piezoelectric (PZT) ceramic element that rapidly contracts and expands when applied a voltage to it. The vibrations of the PZT are transmitted to the mesh membrane, which is in contact with the liquid medication loaded in the medication container. This vibration pushes the liquid or suspension through the fine conical holes of the mesh, forming aerosol droplets for the user to inhale.

AllNEB Breath Actuated Nebulizer is intended for adults and pediatric patients over 5 years old, who are under the care or treatment of a licensed healthcare provider or physician. AllNEB is intended for the administration of aerosolized medication prescribed by a physician or healthcare professional. AllNEB is to be used at home or in hospitals and clinics.

AllNEB is a jet nebulizer intended to administer medication (prescribed by a physician or health care provider) in the form of an aerosol for patient inhalation. It operates in conjunction with a compressed air source and a liquid medication. The subject device is designed to produce and deliver aerosolized medication only during the patient inspiratory cycle, reducing fugitive emissions to the environment. It can be used in hospitals, clinics and in the home.

This product is intended to be used by patients (5+ years) who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers. It is a single patient, multiple use device intended for home use.

The AeroChamber2go* Anti-Static Valved Holding Chamber (VHC) is a portable holding chamber intended to be used by patients (5+ years) who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers. It is a single patient, multiple use device intended for home use. This device is not used with a specific druq nor is it distributed with such drugs.

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.

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.

Model number 1024 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1024 is intended for use only when connected to a 22 mm fitting. Model number 1024A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1024A is intended for use only when connected to a 22 mm fitting. Model number 1025 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1025 is intended for use only when connected to a 22 mm fitting. Model number 1025A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1025A is intended for use only when connected to a 22 mm fitting. Model number 1543 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1543 is intended for use only when connected to a 15 mm fitting. Model number 1543A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1543A is intended for use only when connected to a 15 mm fitting.

Model numbers 1024, 1025, 1543, 1024A, 1025A and 1543A are breathing circuit connectors that function as general purpose actuators for dispensing prescribed aerosolized medication from a pressurized metered dose inhaler (hereafter referred to as "pMDI") canister into a breathing circuit.

The Aerogen® Solo Nebulizer System includes the Aerogen® Solo Nebulizer, which is intended to aerosolize physicianprescribed medications for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment. Aerogen® Solo Nebulizer is for single-patient use. The Aerogen Solo nebulizer is for pediatric (29 days or older) and adult patients. The Aerogen® USB Controller System includes the Aerogen® Solo Nebulizer, which is intended to aerosolize physicianprescribed medications for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment, and on vent only in the homecare environment. Aerogen® Solo Nebulizer is for single patient use. The Aerogen Solo nebulizer is for pediatric (29 days or older) and adult patients.

The Aerogen® Solo Nebulizer System consists of the Aerogen® Solo Nebulizer, which has the proposed modification outlined in these 510(k) applications, and the Aerogen® Pro-X Controller (K133360 for both components and system) or the Aerogen Solo Nebulizer can also be used alternatively with the reference device - Aerogen® USB Controller (K143719). The Aerogen® Solo Nebulizer is intended to aerosolize physician-prescribed medications for inhalation which are approved for use with a general-purpose nebulizer. It is intended for use on and off mechanical ventilation or other positive pressure breathing assistance and is intended for both intermittent and continuous nebulization. The Aerogen® Solo Nebulizer is designed to operate in-line with standard ventilator circuits and mechanical ventilators. It operates without changing patient ventilator parameters and can be refilled without interrupting ventilation. This submission is for a modification of the attachment process of the Aperture Plate (AP) to the Oscillator washer, both are components of the core for the Aerogen® Solo Nebulizer. The current method of attachment of the Aperture Plate to the Oscillator washer is by means of Brazing, a metal fusion process, where a copper/gold filler washer is melted in the brazing process to form the bond. The piezo is then attached using a heat cured epoxy adhesive.

Sodium Chloride Inhalation Solution, USP 3% and 7% The Sodium Chloride Inhalation Solution, USP is used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated. Sodium Chloride Inhalation Solution, USP 0.9% The intended use of this sterile device is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy and for tracheal irrigation or lavage.

The proposed device is a sterile, preservative-free Sodium Chloride Inhalation Solution, USP, provided in concentrations of 0.9%, 3% and 7% with a nominal fill volume of 3 mL & 5 mL (0.9%), 4 mL (3%) and 4 mL (7%) and supplied in single-use low density polyethylene (LDPE) vials.

The AddiPak® Unit Dose Vial may be used in conjunction with a non-ventilator nebulizer for lavage therapy, or for tracheal irrigation. These products are single-use, disposable, and intended for inhalation only.

AddiPak® unit dose solutions are pre-filled vials of bland liquids for inhalation therapy. Contents of these products may be sterile water or a 0.45% sodium chloride solution (half-normal saline). Vials are factory-sealed, made of translucent, color-coded polyethylene, and are available in two sizes (3mL and 5mL). These products are single-use, and intended for inhalation only. Color-coded vials identify contents as sterile water (blue) and half-normal 0.45% saline (green). The pre-filled vials have a perforated, break-away twist cap for dispensing solution. When twisted by the user, cap breaks away and open a small hole for solution to pass through. Vials are designed with inverted graduations to allow the clinician to read volume while dispensing solution. Addipak unit dose vials conforms to the specifications of United States Pharmacopeia – National Formulary, Sterile Water for Inhalation and Sterile Sodium Chloride for Inhalation monograph.

The portable (Ultrasonic) nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (5 years and older), defined by the prescribed medication, and adult patients in hospital/ institutional settings, home, schools, and long-term care facilities. It is not intended for use with Pentamidine.

The Portable (Ultrasonic) nebulizer NBM-1 is small, handheld, internally powered general purpose nebulizer which utilizes ultrasound vibrating mesh technology to generate aerosol. The Portable (Ultrasonic) nebulizer provides a vapor mist of medicine that has much smaller particles and can travel much deeper into the patient's lungs, resulting in much faster relief. The ultrasonic nebulizer is made up of main unit, medicine cup, adult mask, kid mask and mouth piece. The shell of nebulizer, battery cover and spray nozzle are made of ABS, the button decoration ring is silica gel, the medicine cup and button are made by PC, the mask is made of PVC, the mouth piece is made of PP and the nebulizer piece is stainless steel.