Profile: Fisher & Paykel Healthcare designs, manufactures and markets heated humidification devices used in respiratory care & in the treatment of obstructive sleep apnea. We are an ISO 9001 & CE MARK certified company. We offer products for obstructive sleep apnea, respiratory humidification & neonatal. The product neonatal offers infant warming, infant resuscitation & respiratory support. The infant warmer rewarms and stabilizes the newborn baby immediately after delivery. The integrated bassinet and optional accessories offer convenient and easy-to-use equipment for optimal thermal care and resuscitation. Our Neopuff™ infant resuscitator is an easy to use, manually operated, gas-powered resuscitator that provides optimal resuscitation. Our HC150 with ambient tracking® renders humidification benefits of our integrated sleepstyle™ 200 series.

The company has ~300 employees and is ISO 9001, CE certified.

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• Adhesive Bandages (FDA Code: KGX / 880.5240) A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.

• 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.

• Artificial Resuscitator, Infant

• Back-Pressure Compensated Flowmeter (FDA Code: CAX / 868.2340) A compensated thorpe tube flowmeter is a device intended for medical purposes that is used to control and measure gas flow rate accurately. The device includes a vertically mounted tube, with the outlet of the flowmeter calibrated to a reference pressure.

• Battery-Powered Nerve Stimulator (FDA Code: BXN / 868.2775) An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.

• Blenders

• Breathing Circuit Bacterial Filter (FDA Code: CAH / 868.5260) A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.

• Breathing System with/without Controller (FDA Code: BZE / 868.5270) A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.

• Breathing Tube Support (FDA Code: JAY / 868.5280) A breathing tube support is a device that is intended to support and anchor a patient's breathing tube(s).

• Bubble CPAP System

• Constant Voltage Nerve Stimulators

• 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

• CPAP Therapy Accessories

• CPAP Therapy Flow Generators

• CPAP Therapy Headgear

• CPAP Therapy Masks

• CPAP Therapy Seals

• Cylinder/Pipeline Gas Pressure Gauge (FDA Code: BXH / 868.2610) A gas pressure gauge (e.g., bourdon tube pressure gauge) is a device intended for medical purposes that is used to measure gas pressure in a medical gas delivery system.

• Direct Patient Interface Respiratory Gas Humidifier (FDA Code: BTT / 868.5450) A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.

• Disposable Medical Bed (FDA Code: KME / 880.6060) Medical disposable bedding is a device intended for medical purposes to be used by one patient for a period of time and then discarded. This generic type of device may include disposable bedsheets, bedpads, pillows and pillowcases, blankets, emergency rescue blankets, or waterproof sheets.

• Educational Patient Materials

• Electrical Nerve Stimulators

• Endobronchial Tubes & Accessories, CPAP System

• Entrainment Devices

• Extension Airway Connector (FDA Code: BZA / 868.5810) An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.

• Facility Use Minimal Ventilatory Support Continuous Ventilator (FDA Code: MNT / 868.5895)

• Full Face Masks

• Gas Cylinder Pressure Regulator (FDA Code: CAN / 868.2700) A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.

• General Tubing

• Home Phototherapy Equipment

• Humidification Chamber

• Humidification Kits

• Humidification System

• Humidifiers

• Infant Radiant Warmer (FDA Code: FMT / 880.5130) The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.

• Infusion Stand (FDA Code: FOX / 880.6990) The infusion stand is a stationary or movable stand intended to hold infusion liquids, infusion accessories, and other medical devices.

• Manual Feed Adult Chamber

• Manual Feed Infant Chamber

• Mechanical Ventilation Circuits

• Medical Humidifiers

• Nasal Masks

• Nasal Pillows

• Nasal Pillows Mask

• Neonatal Care Devices

• Neonatal Eye Pad (FDA Code: FOK / 880.5270) A neonatal eye pad is an opaque device used to cover and protect the eye of an infant during therapeutic procedures, such as phototherapy.

• Neonatal Infant Warmers