Profile: Respironics, Inc is a resource for respiratory medical devices. We focus on the diagnosis and treatment of sleep disorders. Our 920M plus handheld pulse oximeter provides on-the-spot blood oximetry and heart rate readings that feature a bigger display, better performance and a 72-hour memory. Our PDx portable diagnostic recording device is intended for obstructive sleep apnea screening, follow-up and diagnostic assessment of cardio-respiratory sleep disorders. The flexible and portable system incorporates advanced features. It satisfies the portable testing requirements for levels II, III and IV and provides capabilities of basic screening to advanced diagnostic evaluation. The PDx enables patients to be tested outside of the lab without compromising study results and helps clinicians avoid the costs associated with retesting.

The company was founded in 1976, has ~20 employees and is ISO 9002, CE certified. NASDAQ:RESP (SEC Filings)

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• Actigraphy Kit

• Adult External Negative Pressure Body Ventilator/Cuirass (FDA Code: BYT / 868.5935) An external negative pressure ventilator (e.g., iron lung, cuirass) is a device chamber that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient.

• Aerosol Compressors

• Aerosol Therapy Kits

• Aerosol Therapy Masks

• Aerosol Therapy Masks

• Aerosol Therapy Spacers

• Aerosol Therapy, Holding Chambers

• Airway Pressure Monitor (FDA Code: CAP / 868.2600) An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.

• Airway Pressure Monitor with Alarm (FDA Code: CAP / 868.2600)

• Airway Pressure Monitor with Gauge (FDA Code: CAP / 868.2600)

• Ambulatory Electrocardiograph (FDA Code: MWJ / 870.2800) A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

• Anesthesia Inhalation Breathing Gases Mixer (FDA Code: BZR / 868.5330) A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.

• Anesthesiology Oropharyngeal Airway (FDA Code: CAE / 868.5110) An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.

• Anesthetic Gas Mask (FDA Code: BSJ / 868.5550) An anesthetic gas mask is a device, usually made of conductive rubber, that is positioned over a patient's nose or mouth to direct anesthetic gases to the upper airway.

• Apnea Monitors (FDA Code: FLS / 868.2377) An apnea monitor is a complete system intended to alarm primarily upon the cessation of breathing timed from the last detected breath. The apnea monitor also includes indirect methods of apnea detection such as monitoring of heart rate and other physiological parameters linked to the presence or absence of adequate respiration.

• Aspirators

• Asthma Care Kit for Children

• Batteries & Battery Assemblies for Pulse Oximeters

• Bilevel Airway Pressure Units

• Bilirubin Monitor

• Bleeding Time Device (FDA Code: JCA / 864.6100) A bleeding time device is a device, usually employing two spring-loaded blades, that produces two small incisions in the patient's skin. The length of time required for the bleeding to stop is a measure of the effectiveness of the coagulation system, primarily the platelets.

• Blood Collection Lancet (FDA Code: FMK / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Blood Gas and Ph Electrode Measurement (FDA Code: CHL / 862.1120) A blood gases (PCO2, PO2) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2, PO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

• Blood Gas Monitors

• Blood Partial Pressure Carbon-Dioxide Gas Analyzer

• Blood Phase Partial Pressure Oxygen Gas Analyzers (FDA Code: CCE / 868.1200) An indwelling blood oxygen partial pressure (PO2) analyzer is a device that consists of a catheter-tip PO2transducer (e.g., PO2electrode) and that is used to measure, in vivo, the partial pressure of oxygen in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.

• Breathing Frequency Monitor (FDA Code: BZQ / 868.2375) A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in 868.2377.

• Breathing Mouthpiece (FDA Code: BYP / 868.5620) A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices.

• Calorimeters Diagnostics

• Cannulas

• Capillary Adapter Cleaning Kit

• Capillary Blood Collection Tubes (FDA Code: GIO / 864.6150) A capillary blood collection tube is a plain or heparinized glass tube of very small diameter used to collect blood by capillary action.

• Capnograph

• Capnography Kits

• Carbon-Dioxide Transcutaneous Electrode

• Cardiopulmonary Devices

• Cardiopulmonary Systems

• Cardiorespiratory Monitor

• Co2 Analysis

• Computer Softwares

• Continuing Education Service

• Continuous Electronic Thermometer (FDA Code: FLL / 880.2910) A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

• Continuous Monitor Oxygen Gas Analyzer

• Continuous Positive Airway Pressure Unit

• Continuous Ventilator (FDA Code: CBK / 868.5895) A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

• CPAP Compliance Systems

• CPAP Humidifiers

• CPAP Masks

• CPAP Nasal Systems