Lapas attēli
PDF
ePub
[blocks in formation]

§ 868.5795 Tracheal tube cleaning brush.

(a) 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.

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

[51 FR 40388, Nov. 6, 1986]

§ 868.5800 Tracheostomy tube and tube cuff.

(a) 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'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.

[blocks in formation]

§ 868.5830 Autotransfusion apparatus.

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

(b) Classification. Class II (performance standards).

§ 868.5860 Pressure tubing and accessories.

(a) Identification. Pressure tubing and accessories are flexible or rigid devices intended to deliver pressurized medical gases.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996]

§ 868.5870 Nonrebreathing valve.

(a) Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

(b) Classification. Class II (performance standards).

§ 868.5880 Anesthetic vaporizer.

(a) Identification. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient. (b) Classification. Class II (performance standards).

§ 868.5895 Continuous ventilator.

(a) Identification. 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.

(b) Classification. Class II (performance standards).

[blocks in formation]
[blocks in formation]

(a) Identification. An intermittent mandatory ventilation (IMV) attachment is a device attached to a mechan- | ical ventilator that allows spontaneous breathing by a patient while providing mechanical ventilation at a preset rate.

(b) Classification. Class II (performance standards).

§ 868.5965 Positive end expiratory pressure breathing attachment.

(a) 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's lungs above atmospheric pressure at the end of exhalation.

(b) Classification. Class II (performance standards).

§ 868.5975 Ventilator tubing.

(a) 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.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996]

§ 868.5995 Tee drain (water trap).

(a) Identification. A tee drain (water trap) is a device intended to trap and drain water that collects in ventilator tubing during respiratory therapy, thereby preventing an increase in breathing resistance.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996]

Subpart G-Miscellaneous

§ 868.6100 Anesthetic cabinet, table, or tray.

(a) 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.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[47 FR 31142, July 16. 1982, as amended at 54 FR 25048, June 12, 1989]

§ 868.6175 Cardiopulmonary gency cart.

emer

(a) 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.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. The device is also exempt from the current good manufacturing practice regulations 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.

[47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989]

§ 868.6225 Nose clip.

(a) Identification. A nose clip is a device intended to close a patient's external nares (nostrils) during diagnostic or therapeutic procedures.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. The device is also exempt from the current good manufacturing practice regulations 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.

[47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989]

[blocks in formation]

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1121, Jan. 16, 1996]

§ 868.6885 Medical gas yoke assembly. (a) 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.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1121, Jan. 16, 1996]

[blocks in formation]
[blocks in formation]
[blocks in formation]

870.1025

Arrhythmia detector and alarm.

870.2620

870.1100 Blood pressure alarm. 870.1110 Blood pressure computer. 870.1120 Blood pressure cuff.

870.2640

870.2675

870.2700

[blocks in formation]

Line isolation monitor.

Portable leakage current alarm. Oscillometer.

Oximeter.

870.2710 Ear oximeter.

870.2750 Impedance phlebograph.

870.2770 Impedance plethysmograph.

870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.

870.2800 Medical magnetic tape recorder.

870.2810 Paper chart recorder.

870.2840 Apex cardiographic transducer.

870.2850 Extravascular blood pressure trans

ducer.

870.2860 Heart sound transducer.

870.2870 Catheter tip pressure transducer. Ultrasonic transducer.

Vessel occlusion transducer. 870.2900 Patient transducer and electrode cable (including connector).

[blocks in formation]

870.2880

870.2890

for percutaneous

[blocks in formation]

870.2910 Radiofrequency physiological sig

nal transmitter and receiver.

870.2920 Telephone

electrocardiograph

transmitter and receiver.

[ocr errors][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small]
« iepriekšējāTurpināt »