Source: http://www.boydtech.com/device-finder/anesthesiology
Timestamp: 2019-04-24 20:56:18
Document Index: 154309545

Matched Legal Cases: ['art 868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', 'art 807', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868', '§868']

Anesthesiology | Boyd Technologies
Anesthesiology is a practice in medicine that provides relief of pain and total care of a patient before, during, and after surgery. The FDA regulates devices used in the practice of anesthesiology under CFR Title 21 Part 868, and the devices are categorized into four subparts.
Anesthesiology Diagnostic Devices
Anesthesiology Monitoring Devices
Anesthesiology Therapeutic Devices
Additional Factors/Tools
§868.1030
Identification. A manual algesimeter is a mechanical device intended to determine a patient&#39;s sensitivity to pain after administration of an anesthetic agent, e.g., by pricking with a sharp point.
§868.1040
Identification. A powered algesimeter is a device using electrical stimulation intended to determine a patient&#39;s sensitivity to pain after administration of an anesthetic agent.
§868.1075
Identification. An argon gas analyzer is a device intended to measure the concentration of argon in a gas mixture to aid in determining the patient&#39;s ventilatory status. The device may use techniques such as mass spectrometry or thermal conductivity.
§868.1100
Identification. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin.
§868.1120
Identification. An indwelling blood oxyhemoglobin concentration analyzer is a photoelectric device used to measure, in vivo, the oxygen-carrying capacity of hemoglobin in blood to aid in determining the patient&#39;s physiological status.
§868.1150
Identification. An indwelling blood carbon dioxide partial pressure PCO2 analyzer is a device that consists of a catheter-tip PCO2 transducer (e.g., PCO2 electrode) and that is used to measure, in vivo, the partial pressure of carbon dioxide in blood to aid in determining the patient&#39;s circulatory, ventilatory, and metabolic status.
Classification. Class II (special controls). The special control for this device is FDA&#39;s Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.
§868.1170
Identification. An indwelling blood hydrogen ion concentration (pH) analyzer is a device that consists of a catheter-tip pH electrode and that is used to measure, in vivo, the hydrogen ion concentration (pH) in blood to aid in determining the patient&#39;s acid-base balance.
§868.1200
Identification. An indwelling blood oxygen partial pressure (PO2) analyzer is a device that consists of a catheter-tip PO2 transducer (e.g., PO2 electrode) and that is used to measure, in vivo, the partial pressure of oxygen in blood to aid in determining the patient&#39;s circulatory, ventilatory, and metabolic status.
§868.1400
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient&#39;s ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.
§868.1430
Identification. A carbon monoxide gas analyzer is a device intended to measure the concentration of carbon monoxide in a gas mixture to aid in determining the patient&#39;s ventilatory status. The device may use techniques such as infrared absorption or gas chromatography.
§868.1500
§868.1575
Identification. A gas collection vessel is a container-like device intended to collect a patient&#39;s exhaled gases for subsequent analysis. It does not include a sampling pump.
§868.1620
§868.1640
§868.1670
§868.1690
Identification. A nitrogen gas analyzer is a device intended to measure the concentration of nitrogen in respiratory gases to aid in determining a patient&#39;s ventilatory status. The device may use techniques such as gas chromatography or mass spectrometry.
§868.1700
§868.1720
§868.1730
Identification. An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a patient and may include components for determining expired gas volume and composition.
§868.1750
Identification. A pressure plethysmograph is a device used to determine a patient&#39;s airway resistance and lung volumes by measuring pressure changes while the patient is in an airtight box.
§868.1760
Identification. A volume plethysmograph is an airtight box, in which a patient sits, that is used to determine the patient&#39;s lung volume changes.
§868.1780
Identification. An inspiratory airway pressure meter is a device used to measure the amount of pressure produced in a patient&#39;s airway during maximal inspiration.
§868.1800
Identification. A rhinoanemometer is a device used to quantify the amount of nasal congestion by measuring the airflow through, and differential pressure across, a patient&#39;s nasal passages.
§868.1840
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient&#39;s lungs.
§868.1850
Identification. A monitoring spirometer is a device used to measure continuously a patient&#39;s tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient&#39;s ventilatory status.
§868.1860
Identification. A peak-flow meter for spirometry is a device used to measure a patient&#39;s maximum ventilatory flow rate.
§868.1870
§868.1880
§868.1890
§868.1900
Identification. A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.
§868.1910
Identification. An esophageal stethoscope is a nonpowered device that is inserted into a patient&#39;s esophagus to enable the user to listen to heart and breath sounds.
§868.1920
Identification. An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient&#39;s heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement.
§868.1930
Identification. A stethoscope head is a weighted chest piece used during anesthesia to listen to a patient&#39;s heart, breath, and other physiological sounds.
§868.1965
Identification. A switching valve (ploss) is a three-way valve located between a stethoscope placed over the heart, a blood pressure cuff, and an earpiece. The valve allows the user to eliminate one sound channel and listen only to a patient&#39;s heart or korotkoff (blood pressure) sounds through the other channel.
§868.1975
Identification. A water vapor analyzer is a device intended to measure the concentration of water vapor in a patient&#39;s expired gases by using techniques such as mass spectrometry.
§868.2025
Identification. An ultrasonic air embolism monitor is a device used to detect air bubbles in a patient&#39;s blood stream. It may use Doppler or other ultrasonic principles.
§868.2300
§868.2320
Identification. An uncompensated thorpe tube flowmeter is a device intended for medical purposes that is used to indicate and control gas flow rate accurately. The device includes a vertically mounted tube and is calibrated when the outlet of the flowmeter is open to the atmosphere.
§868.2340
Identification. 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.
§868.2350
§868.2375
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient&#39;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.
§868.2377
Identification. 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.
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA.
§868.2380
Classification. Class II. The special control for this device is FDA&#39;s Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.
§868.2385
§868.2450
Identification. A lung water monitor is a device used to monitor the trend of fluid volume changes in a patient&#39;s lung by measuring changes in thoracic electrical impedance (resistance to alternating current) by means of electrodes placed on the patient&#39;s chest.
§868.2480
Identification. A cutaneous carbon dioxide (PcCO2) monitor is a noninvasive heated sensor and a pH-sensitive glass electrode placed on a patient&#39;s skin, which is intended to monitor relative changes in a hemodynamically stable patient&#39;s cutaneous carbon dioxide tension as an adjunct to arterial carbon dioxide tension measurement.
Classification. Class II (special controls). The special control for this device is FDA&#39;s Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA. See 868.1(e) for the availability of this guidance document.
§868.2500
Identification. A cutaneous oxygen (PcO2) monitor is a noninvasive, heated sensor (e.g., a Clark-type polargraphic electrode) placed on the patient&#39;s skin that is intended to monitor relative changes in the cutaneous oxygen tension.
§868.2550
§868.2600
Identification. An airway pressure monitor is a device used to measure the pressure in a patient&#39;s upper airway. The device may include a pressure gauge and an alarm.
§868.2610
§868.2620
§868.2700
§868.2775
§868.2875
§868.2885
§868.2900
§868.5090
Identification. An emergency airway needle is a device intended to puncture a patient&#39;s cricothyroid membrane to provide an emergency airway during upper airway obstruction.
§868.5100
Identification. A nasopharyngeal airway is a device used to aid breathing by means of a tube inserted into a patient&#39;s pharynx through the nose to provide a patent airway.
§868.5110
Identification. An oropharyngeal airway is a device inserted into a patient&#39;s pharynx through the mouth to provide a patent airway.
§868.5115
Classification. Class II (special controls) (Class II Special Control Guidance Document for Acute Upper Airway Obstruction Devices). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to 868.9.
§868.5120
§868.5130
Identification. An anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid.
§868.5140
§868.5150
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.
Gas machine for anesthesia(1) Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient&#39;s ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply. (2) Classification. Class II (performance standards).
Gas machine for analgesia(1) Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide). (2) Classification. Class II (performance standards).
§868.5165
§868.5170
Identification. A laryngotracheal topical anesthesia applicator is a device used to apply topical anesthetics to a patient&#39;s laryngotracheal area.
§868.5180
Identification. A rocking bed is a device intended for temporary use to help patient ventilation (breathing) by repeatedly tilting the patient, thereby using the weight of the abdominal contents to move the diaphragm.
§868.5220
§868.5240
§868.5250
§868.5260
§868.5270
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient&#39;s airway. The device may include a temperature controller.
§868.5280
Identification. A breathing tube support is a device that is intended to support and anchor a patient&#39;s breathing tube(s).
§868.5300
§868.5310
§868.5320
Identification. 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&#39;s ventilation.
§868.5330
Identification. 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.
§868.5340
Identification. A nasal oxygen cannula is a two-pronged device used to administer oxygen to a patient through both nostrils.
§868.5350
Identification. A nasal oxygen catheter is a device intended to be inserted through a patient&#39;s nostril to administer oxygen.
§868.5365
Identification. A posture chair for cardiac or pulmonary treatment is a device intended to assist in the rehabilitation and mobilization of patients with chronic heart or lung disease.
§868.5375
§868.5400
Identification. An electroanesthesia apparatus is a device used for the induction and maintenance of anesthesia during surgical procedures by means of an alternating or pulsed electric current that is passed through electrodes fixed to a patient&#39;s head.
§868.5420
Identification. An ether hook is a device that fits inside a patient&#39;s mouth and that is intended to deliver vaporized ether.
Identification. A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient&#39;s breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system.
§868.5440
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).
§868.5450
§868.5460
Identification. A therapeutic humidifier for home use is a device that adds water vapor to breathing gases and that is intended for respiratory therapy or other medical purposes. The vapor produced by the device pervades the area surrounding the patient, who breathes the vapor during normal respiration.
§868.5470
Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient&#39;s tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (878.5650).
§868.5530
Identification. A flexible laryngoscope is a fiberoptic device used to examine and visualize a patient&#39;s upper airway and aid placement of a tracheal tube.
§868.5540
Identification. A rigid laryngoscope is a device used to examine and visualize a patient&#39;s upper airway and aid placement of a tracheal tube.
§868.5550
Identification. An anesthetic gas mask is a device, usually made of conductive rubber, that is positioned over a patient&#39;s nose or mouth to direct anesthetic gases to the upper airway.
§868.5560
Identification. A gas mask head strap is a device used to hold an anesthetic gas mask in position on a patient&#39;s face.
§868.5570
Identification. A nonrebreathing mask is a device fitting over a patient&#39;s face to administer oxygen. It utilizes one-way valves to prevent the patient from rebreathing previously exhaled gases.
§868.5580
Identification. An oxygen mask is a device placed over a patient&#39;s nose, mouth, or tracheostomy to administer oxygen or aerosols.
§868.5590
Identification. A scavenging mask is a device positioned over a patient&#39;s nose to deliver anesthetic or analgesic gases to the upper airway and to remove excess and exhaled gas. It is usually used during dentistry.
§868.5600
Identification. A venturi mask is a device containing an air-oxygen mixing mechanism that dilutes 100 percent oxygen to a predetermined concentration and delivers the mixed gases to a patient.
Breathing mouthpiece.
§868.5620
Identification. A breathing mouthpiece is a rigid device that is inserted into a patient&#39;s mouth and that connects with diagnostic or therapeutic respiratory devices.
§868.5630
§868.5640
Identification. A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe.
§868.5650
Identification. An esophageal obturator is a device inserted through a patient&#39;s mouth to aid ventilation of the patient during emergency resuscitation by occluding (blocking) the esophagus, thereby permitting positive pressure ventilation through the trachea. The device consists of a closed-end semirigid esophageal tube that is attached to a face mask.
§868.5655
Identification. A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug.
§868.5665
Identification. A powered percussor is a device that is intended to transmit vibration through a patient&#39;s chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.
§868.5675
Identification. A rebreathing device is a device that enables a patient to rebreathe exhaled gases. It may be used in conjunction with pulmonary function testing or for increasing minute ventilation.
§868.5690
Identification. An incentive spirometer is a device that indicates a patient&#39;s breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.
Nonpowered oxygen tent.
§868.5700
Identification. A nonpowered oxygen tent is a device that encloses a patient&#39;s head and upper body to contain oxygen delivered to the patient for breathing. This generic type of device includes infant oxygen hoods.
§868.5710
Identification. An electrically powered oxygen tent is a device that encloses a patient&#39;s head and, by means of an electrically powered unit, administers breathing oxygen and controls the temperature and humidity of the breathing gases. This generic type device includes the pediatric aerosol tent.
§868.5720
Identification. A bronchial tube is a device used to differentially intubate a patient&#39;s bronchus (one of the two main branches of the trachea leading directly to the lung) in order to isolate a portion of lung distal to the tube.
§868.5730
Identification. A tracheal tube is a device inserted into a patient&#39;s trachea via the nose or mouth and used to maintain an open airway.
§868.5740
§868.5750
Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient&#39;s trachea.
§868.5760
§868.5770
Identification. A tracheal tube fixation device is a device used to hold a tracheal tube in place, usually by means of straps or pinch rings.
§868.5780
Identification. Tube introduction forceps (e.g., Magill forceps) are a right-angled device used to grasp a tracheal tube and place it in a patient&#39;s trachea.
§868.5790
Identification. A tracheal tube stylet is a device used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
§868.5795
Identification. A tracheal tube cleaning brush is a device consisting of a brush with plastic bristles intended to clean tracheal cannula devices after their removal from patients.
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient&#39;s aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.
§868.5810
Identification. An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.
§868.5820
Identification. A dental protector is a device intended to protect a patient&#39;s teeth during manipulative procedures within a patient&#39;s oral cavity.
§868.5830
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.
§868.5860
Identification. Pressure tubing and accessories are flexible or rigid devices intended to deliver pressurized medical gases.
Nonrebreathing valve.
§868.5870
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.
§868.5880
Identification. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.
§868.5895
§868.5905
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient&#39;s lungs or to assist a patient&#39;s breathing.
§868.5915
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient&#39;s airway.
§868.5925
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient&#39;s airway.
§868.5935
Identification. An external negative pressure ventilator (e.g., iron lung, cuirass) is a device chamber that is intended to support a patient&#39;s ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient.
§868.5955
§868.5965
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient&#39;s lungs above atmospheric pressure at the end of exhalation.
Identification. Ventilator tubing is a device intended for use as a conduit for gases between a ventilator and a patient during ventilation of the patient.
§868.5995
§868.6100
Identification. An anesthetic cabinet, table, or tray is a device intended to store anesthetic equipment and drugs. The device is usually constructed to eliminate build-up of static electrical charges.
§868.6175
Identification. A cardiopulmonary emergency cart is a device intended to store and transport resuscitation supplies for emergency treatment. The device does not include any equipment used in cardiopulmonary resuscitation.
§868.6225
Identification. A nose clip is a device intended to close a patient&#39;s external nares (nostrils) during diagnostic or therapeutic procedures.
§868.6250
Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.
§868.6400
§868.6700
Identification. An anesthesia stool is a device intended for use as a stool for the anesthesiologist in the operating room.
§868.6810
Identification. A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient&#39;s upper airway.
§868.6820
§868.6885
Identification. A medical gas yoke assembly is a device intended to connect medical gas cylinders to regulators or needle valves to supply gases for anesthesia or respiratory therapy. The device may include a particulate filter.