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.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Identification. An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.

Classification. Class II (performance standards).

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.

Classification. Class II (performance standards).

Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

Classification. Class II (performance standards).

Identification. 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.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

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.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

Classification. Class II (performance standards).

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.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Identification. The nitric oxide administration apparatus is a device used to add nitric oxide to gases that are to be breathed by a patient. The nitric oxide administration apparatus is to be used in conjunction with a ventilator or other breathing gas administration system.

Classification. Class II. The special control for this device is FDA's "Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer."

Identification. 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.

Classification. Class II (performance standards).

Identification. 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.

Classification. Class II (special controls). The special control for this device is FDA's "Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA."

Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled "Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers." Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in 880.9.

Identification. A blow bottle is a device that is intended for medical purposes to induce a forced expiration from a patient. The patient blows into the device to move a column of water from one bottle to another.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Identification. A bourdon gauge flowmeter is a device intended for medical purposes that is used in conjunction with respiratory equipment to sense gas pressure. The device is calibrated to indicate gas flow rate when the outflow is open to the atmosphere.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.

Classification. Class II (performance standards).

Identification. A breathing circuit circulator is a turbine device that is attached to a closed breathing circuit and that is intended to circulate anesthetic gases continuously by maintaining the unidirectional valves in an open position and reducing mechanical dead space and resistance in the breathing circuit.

Classification. Class II (performance standards).

Identification. 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.

Classification. Class II (performance standards).

Identification. A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 868.9.

Identification. 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.

Classification. Class II (performance standards).

Identification. A breathing tube support is a device that is intended to support and anchor a patient's breathing tube(s).

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.