Profile: Hans Rudolph, inc. is a designer and manufacturer of respiratory valves and other respiratory products. Our products include breathing valves, non-diffusing gas bags, nose clips, mouthpieces, respiratory control circuit valves both manual and automatic, valve controllers, flow resistance standards, pneumotachometers, exercise and stress test breathing masks and valves, oro-nasal CPAP, BILEVEL & NIV masks, metro sealsT, volume calibration syringes, research pneumotach systems, pneumotach amplifiers, & lung simulators. NEW PRODUCTS include silicone rubber mouthpieces, DLco simulator, flow/volume simulator, oro-nasal V2TM CPAP/BILEVEL/NIV masks disposable & reusable, disposable & reusable nose clips, & metro sealT - NG tube seals for oro-nasal mask.

FDA Registration Number: 1922553

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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.

• Airflow Pressure Transducers

• 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.

• 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.

• Breathing Simulator and Remote Monitor Software

• 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).

• Calibration Equipment

• Calibration Syringe

• 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 Masks

• CPAP Nasal Systems

• CPAP Therapy Accessories

• CPAP Therapy Headgear

• CPAP Therapy Masks

• CPAP Therapy Seals

• Diagnostic Flow Sensors

• Diffusion Capacity Testing Device

• Disposable Spiro Nose Clips

• Dual Port Silicone Rubber Face Mask

• Equipment Testing Services

• Exercise Testing Equipment

• Flow Sensors

• Gas Volume Calibrator (FDA Code: BXW / 868.1870) A gas volume calibrator is a device that is intended for medical purposes and that is used to calibrate the output of gas volume measurement instruments by delivering a known gas volume.

• Hyperbaric Therapy

• Intraprocedural Equipment, Adapters & Connectors

• Lung Analyzers

• Lung-volume Testing Equipment

• Mechanical Ventilation Circuits

• Non-Continuous Ventilator/Respirator (FDA Code: BZD / 868.5905) A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

• Non-Diffusing Gas Bag

• Non-Rebreathing Oxygen Mask (FDA Code: KGB / 868.5570) A nonrebreathing mask is a device fitting over a patient's face to administer oxygen. It utilizes one-way valves to prevent the patient from rebreathing previously exhaled gases.

• Non-Rebreathing Valve (FDA Code: CBP / 868.5870) A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

• Nose Clips (FDA Code: BXJ / 868.6225) A nose clip is a device intended to close a patient's external nares (nostrils) during diagnostic or therapeutic procedures.

• One-Way Non Rebreathing Valves

• Oral CPAP Therapy Kit

• Oxygen Masks (FDA Code: BYG / 868.5580) An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.

• Plastic Nose Clip

• Pneumotachographs

• Positive Airway Pressure Therapy Valves

• Positive Airway Pressure Therapy, Headgear

• Positive Airway Pressure Therapy, Masks

• Pressure Airflow Sensors

• Pressure Plethysmograph (FDA Code: CCM / 868.1750) A pressure plethysmograph is a device used to determine a patient's airway resistance and lung volumes by measuring pressure changes while the patient is in an airtight box.

• Pressure Tubing and Accessories (FDA Code: BYX / 868.5860) Pressure tubing and accessories are flexible or rigid devices intended to deliver pressurized medical gases.

• Pulmonary Function Data Calculator (FDA Code: BZC / 868.1880) A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.

• Pulmonary Pneumotachometer (FDA Code: JAX / 868.2550) A pneumotachometer is a device intended for medical purposes that is used to determine gas flow by measuring the pressure differential across a known resistance. The device may use a set of capillaries or a metal screen for the resistive element.

• Quality Control Calibration

• Quality Control Kits (FDA Code: JTR / 866.2480) A quality control kit for culture media is a device that consists of paper discs (or other suitable materials), each impregnated with a specified, freeze-dried, viable microorganism, intended for medical purposes to determine if a given culture medium is able to support the growth of that microorganism. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

• Quality Testing Equipment

• Reservoir Bag (FDA Code: BTC / 868.5320) A reservoir bag is a device, usually made of conductive rubber, intended for use in a breathing circuit as a reservoir for breathing gas and to assist, control, or monitor a patient's ventilation.