21 CFR Part 868 — Anesthesiology Devices
Subpart A — General Provisions
Subpart B — Diagnostic Devices
- § 868.1030— Manual algesimeter.
- § 868.1040— Powered algesimeter.
- § 868.1075— Argon gas analyzer.
- § 868.1100— Arterial blood sampling kit.
- § 868.1120— Indwelling blood oxyhemoglobin concentration analyzer.
- § 868.1150— Indwelling blood carbon dioxide partial pressure (P<sub>2CO2</sub>) analyzer.
- § 868.1170— Indwelling blood hydrogen ion concentration (pH) analyzer.
- § 868.1200— Indwelling blood oxygen partial pressure (P<sub>O2</sub>) analyzer.
- § 868.1400— Carbon dioxide gas analyzer.
- § 868.1430— Carbon monoxide gas analyzer.
- § 868.1500— Enflurane gas analyzer.
- § 868.1505— Ventilatory electrical impedance tomograph.
- § 868.1575— Gas collection vessel.
- § 868.1620— Halothane gas analyzer.
- § 868.1640— Helium gas analyzer.
- § 868.1670— Neon gas analyzer.
- § 868.1690— Nitrogen gas analyzer.
- § 868.1700— Nitrous oxide gas analyzer.
- § 868.1720— Oxygen gas analyzer.
- § 868.1730— Oxygen uptake computer.
- § 868.1750— Pressure plethysmograph.
- § 868.1760— Volume plethysmograph.
- § 868.1780— Inspiratory airway pressure meter.
- § 868.1800— Rhinoanemometer.
- § 868.1840— Diagnostic spirometer.
- § 868.1850— Monitoring spirometer.
- § 868.1860— Peak-flow meter for spirometry.
- § 868.1870— Gas volume calibrator.
- § 868.1880— Pulmonary-function data calculator.
- § 868.1890— Predictive pulmonary-function value calculator.
- § 868.1900— Diagnostic pulmonary-function interpretation calculator.
- § 868.1910— Esophageal stethoscope.
- § 868.1920— Esophageal stethoscope with electrical conductors.
- § 868.1930— Stethoscope head.
- § 868.1965— Switching valve (ploss).
- § 868.1975— Water vapor analyzer.
Subpart C — Monitoring Devices
- § 868.2025— Ultrasonic air embolism monitor.
- § 868.2300— Bourdon gauge flowmeter.
- § 868.2320— Uncompensated thorpe tube flowmeter.
- § 868.2340— Compensated thorpe tube flowmeter.
- § 868.2350— Gas calibration flowmeter.
- § 868.2375— Breathing frequency monitor.
- § 868.2377— Apnea monitor.
- § 868.2380— Nitric oxide analyzer.
- § 868.2385— Nitrogen dioxide analyzer.
- § 868.2450— Lung water monitor.
- § 868.2480— Cutaneous carbon dioxide (PcCO2) monitor.
- § 868.2500— Cutaneous oxygen (PcO2) monitor.
- § 868.2550— Pneumotachometer.
- § 868.2600— Airway pressure monitor.
- § 868.2610— Gas pressure gauge.
- § 868.2620— Gas pressure calibrator.
- § 868.2700— Pressure regulator.
- § 868.2775— Electrical peripheral nerve stimulator.
- § 868.2875— Differential pressure transducer.
- § 868.2885— Gas flow transducer.
- § 868.2900— Gas pressure transducer.
Subpart F — Therapeutic Devices
- § 868.5090— Emergency airway needle.
- § 868.5095— Retrograde intubation device.
- § 868.5100— Nasopharyngeal airway.
- § 868.5105— External negative pressure airway aid.
- § 868.5110— Oropharyngeal airway.
- § 868.5115— Device to relieve acute upper airway obstruction.
- § 868.5120— Anesthesia conduction catheter.
- § 868.5130— Anesthesia conduction filter.
- § 868.5140— Anesthesia conduction kit.
- § 868.5150— Anesthesia conduction needle.
- § 868.5160— Gas machine for anesthesia or analgesia.
- § 868.5165— Nitric oxide administration apparatus.
- § 868.5170— Laryngotracheal topical anesthesia applicator.
- § 868.5180— Rocking bed.
- § 868.5220— Blow bottle.
- § 868.5240— Anesthesia breathing circuit.
- § 868.5250— Breathing circuit circulator.
- § 868.5260— Breathing circuit bacterial filter.
- § 868.5270— Breathing system heater.
- § 868.5273— Positive airway pressure delivery system.
- § 868.5280— Breathing tube support.
- § 868.5300— Carbon dioxide absorbent.
- § 868.5310— Carbon dioxide absorber.
- § 868.5320— Reservoir bag.
- § 868.5330— Breathing gas mixer.
- § 868.5340— Nasal oxygen cannula.
- § 868.5350— Nasal oxygen catheter.
- § 868.5365— Posture chair for cardiac or pulmonary treatment.
- § 868.5375— Heat and moisture condenser (artificial nose).
- § 868.5400— Electroanesthesia apparatus.
- § 868.5420— Ether hook.
- § 868.5430— Gas-scavenging apparatus.
- § 868.5440— Portable oxygen generator.
- § 868.5450— Respiratory gas humidifier.
- § 868.5454— High flow humidified oxygen delivery device.
- § 868.5460— Therapeutic humidifier for home use.
- § 868.5470— Hyperbaric chamber.
- § 868.5480— Isocapnic ventilation device.
- § 868.5530— Flexible laryngoscope.
- § 868.5540— Rigid laryngoscope.
- § 868.5550— Anesthetic gas mask.
- § 868.5560— Gas mask head strap.
- § 868.5570— Nonrebreathing mask.
- § 868.5580— Oxygen mask.
- § 868.5590— Scavenging mask.
- § 868.5600— Venturi mask.
- § 868.5620— Breathing mouthpiece.
- § 868.5630— Nebulizer.
- § 868.5640— Medicinal nonventilatory nebulizer (atomizer).
- § 868.5650— Esophageal obturator.
- § 868.5655— Portable liquid oxygen unit.
- § 868.5665— Powered percussor.
- § 868.5675— Rebreathing device.
- § 868.5690— Incentive spirometer.
- § 868.5700— Nonpowered oxygen tent.
- § 868.5710— Electrically powered oxygen tent.
- § 868.5720— Bronchial tube.
- § 868.5730— Tracheal tube.
- § 868.5740— Tracheal/bronchial differential ventilation tube.
- § 868.5750— Inflatable tracheal tube cuff.
- § 868.5760— Cuff spreader.
- § 868.5770— Tracheal tube fixation device.
- § 868.5780— Tube introduction forceps.
- § 868.5790— Tracheal tube stylet.
- § 868.5795— Tracheal tube cleaning brush.
- § 868.5800— Tracheostomy tube and tube cuff.
- § 868.5810— Airway connector.
- § 868.5820— Dental protector.
- § 868.5830— Autotransfusion apparatus.
- § 868.5860— Pressure tubing and accessories.
- § 868.5870— Nonrebreathing valve.
- § 868.5880— Anesthetic vaporizer.
- § 868.5895— Continuous ventilator.
- § 868.5905— Noncontinuous ventilator (IPPB).
- § 868.5915— Manual emergency ventilator.
- § 868.5925— Powered emergency ventilator.
- § 868.5935— External negative pressure ventilator.
- § 868.5955— Intermittent mandatory ventilation attachment.
- § 868.5965— Positive end expiratory pressure breathing attachment.
- § 868.5975— Ventilator tubing.
- § 868.5995— Tee drain (water trap).
Subpart G — Miscellaneous
- § 868.6100— Anesthetic cabinet, table, or tray.
- § 868.6175— Cardiopulmonary emergency cart.
- § 868.6225— Nose clip.
- § 868.6250— Portable air compressor.
- § 868.6400— Calibration gas.
- § 868.6700— Anesthesia stool.
- § 868.6810— Tracheobronchial suction catheter.
- § 868.6820— Patient position support.
- § 868.6885— Medical gas yoke assembly.