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The eRapid NCP Nebulizer System is to be used with patients for whom doctors have prescribed medicine for nebulization. It is intended for adult and pediatric patients age 4 and older who can coordinate breathing through a mouthpiece, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments.

Both the eRapid NCP and the predicate eRapid device are identical in purpose, function, core technology and method of operation. They are single-patient use, reusable electronic nebulizers, using micro-perforated vibrating membrane technology to aerosolize liquid medications. They are for adult and pediatric inhalation therapy in a home care, nursing home, sub-acute institution, or hospital environment. The devices are hand-held and portable, consisting of a controller and a nebulizer handset, connected with a connection cord. Power input for both devices is provided by either AA batteries, or a DC or AC adapter. Alternate power cords, plugs and adapters allow their use in any country.

The PARI Proneb Max is a tabletop, AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers with patients for whom doctors have prescribed medication. It is intended for adult and pediatric patients 2 years and older, and may be used in hospital-type facilities, nursing homes, sub-acute institutions and home environments.

The Proneb Max is a tabletop air compressor for use with jet nebulizers, which aerosolize liquid medications for inhalation by patients with respiratory diseases and conditions. The Proneb Max is to be used with adult and pediatric patients ages 2 years and older, and is intended for sale by prescription only. It may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments. It is provided non-sterile. The Proneb Max compressor creates an airflow that travels to the nebulizer through tubing. The nebulizer is attached to the compressor for its operation. The Proneb Max compressor is constructed of (1) Teflon; (2) ABS; (3) PBT GF30 and, has the following principal internal subcomponents: (1) cylinder/valve system; (2) piston rod/piston sealing: (3) a patient interface (on/off switch): (4) motor 120V/60Hz: (5) power cord/wire harness; and (6) hoses. Energy source for the device is provided by connection to a 120V/60 Hz mains power source.

The Velox Nebulizer System is a handheld nebulizer that is to be used with patients for whom doctors have prescribed medication for nebulization. It is intended for adult and pediatric patients 4 years and older who can coordinate breathing through a mouthpiece, and may be used in hospital-type facilities, nursing homes, sub-acute institutions and home environments.

The Velox Nebulizer System is a portable, reusable, single-patient use, handheld electronic nebulizer that uses a piezo-driven, micro-perforated vibrating membrane technology to aerosolize liquid medications for the treatment or prophylaxis of respiratory diseases. It is to be used with adult and pediatric patients for whom doctors have prescribed medication, i.e. it is for prescription use only. It may be used in hospital-type facilities, nursing homes, sub-acute institutions and home environments. It is provided non-sterile. The device consists of two major components: the nebulizer and a Controller. The nebulizer contains a medication cap, medication reservoir, aerosol head, aerosol chamber, and mouthpiece. The Controller contains a circuit board, USB connector, patient interface (on/off switch), and AA battery housing. The controller's functions are to conduct power pre-processing, supervise aerosol generation through incorporated software, and generate optical and acoustical feedback to the user. The device is powered by connection to a mains power source via an AC Power Supply or disposable/rechargeable AA batteries. Associated accessories include a cleaning aid and an AC Power Supply.

The PARI O-PEP is intended for use as a Positive Expiratory Pressure Device, and is designed to help patients improve secretion clearance. The PARI O-PEP is intended for adult and pediatric patients ages 5 and older, for use in home, hospital, and sub-acute institutions.

The PARI O-PEP (Oscillating Positive Expiratory Pressure) is a small, single patient use, reusable oscillating PEP therapy device. The PARI O-PEP is a respiratory therapy device designed for temporary application to mobilize secretions or mucous in the lower respiratory tract, strengthen the respiratory tract and alleviate shortness of breath. The patient exhales repeatedly into the device against a movable ball, causing a vibration that is transmitted to the lungs. This causes the deeper respiratory tract to open. By doing this, secretions are mobilized and able to move up the airways. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.

The eRapid™ Nebulizer System is a handheld nebulizer that will be used with patients for whom doctors have prescribed medication for nebulization. It is intended for adult and pediatric patients, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments.

The eRapid Nebulizer System is a modified version of the predicate FDA-cleared eFlow (now Trio ) Electronic Nebulizer, cleared in 510k Nos. K033833 and Special 510K No. K072670, and the Altera® Nebulizer System, cleared in 510(k) No. K100380. Its performance characteristics, however, are comparable to the predicates LC Star, cleared in 510(k) No. K963924, and Micro Mist Nebulizer, cleared in 510(k) No. K930525. Similarities are that both the eRapid and the predicate Trio and Altera devices are identical in purpose, function, core technology and method of operation. They are singlepatient use, reusable electronic nebulizers, using micro-perforated vibrating membrane technology to aerosolize liquid medications. They are for adult and pediatric inhalation therapy in a home care, nursing home, sub-acute institution, or hospital environment. The devices are hand-held and portable, consisting of a controller and a nebulizer handset, connected with a connection cord. Power input for both devices is provided by either four AA batteries, or a DC or AC adapter. Alternate power cords, plugs and adapters allow their use in any country. The eRapid incorporates three design modifications in comparison with the predicate eFlow Technology devices: (1) a larger capacity reservoir, and a smaller volume aerosol chamber; (2) for patient convenience, an accessory that aids in the cleaning of the aerosol head, and; (3) also for patient convenience, added software user-interface functions that allow the device to pause in its operation, as well as to operate the cleaning aid. Also. while the eRapid and the predicates Trio. LC Star and Micro Mist are for use with those medications prescribed by doctors for nebulization (i.e. general purpose) the Altera has a drug-specific application.

The PARI Sinus is a compressor nebulizer system, designed to aerosolize medication approved for nebulization and prescribed by a physician for delivery to the upper airways. The PARI Sinus is intended for adult and pediatric patients consistent with the indications for aerosol medication, in homes, hospitals, and sub-acute institutions.

The PARI Sinus is a single patient use, reusable aerosol therapy device for delivery of prescribed medications to the upper airway. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments. The PARI Sinus utilizes a combination of aerosol flow and vibration to effectively deliver aerosolized medications to the upper airway.

The Altera" Nebulizer System is intended specifically for the aerosolization of Cayston" (aztreonam for inhalation solution) using vibrating membrane technology. The device is intended for adult and pediatric patients who have been prescribed Cayston, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments.

The Altera™ Nebulizer System (hereinafter referred to as "Altera") is a drug specific version of the FDA-cleared eFlow Electronic Nebulizer, originally cleared in 510k No. K033833, and as modified in Special 510K No. K072670. Both the Altera and the predicate eFlow are identical in purpose, function, core technology, basic design, materials and method of operation. They are single-patient use, reusable electronic nebulizers that employ micro-perforated vibrating membrane technology to aerosolize liquid medications. They are for adult and pediatric inhalation therapy in a home care, nursing home, sub-acute institution, or hospital environment. Both devices are hand-held and portable, consisting of a control, or base unit and a nebulizer handset, connected with a connection cord. Power input for both the Altera and the predicate eFlow is provided by either four AA batteries or a DC or AC adapter. Alternate power cords, plugs and adapters allow their use in any country. However, unlike the predicate eFlow the Altera is drug-specific, intended for use only with aztreonam for inhalation solution.

The PARI Vios is a tabletop, AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The PARI Vios is intended for adult and pediatric patients for use in hospital, clinic, or home environments.

The PARI Vios nebulizer compressor is a small, lightweight AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The device is non-sterile and prescriptionuse only.

The PARI PEP S is intended for use as a Positive Expiratory Pressure Device, and is designed to help patients exercise their lungs properly and improve secretion clearance. The PARI PEP S may be used by itself or in conjunction with aerosol drug therapy. The PARI PEP S is intended for adult and pediatric patients, for use in home, hospital, and sub-acute institutions.

The PARI PEP S is a small, single patient use, reusable PEP therapy device for use as a stand alone PEP device or for use with aerosol drug delivery. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.