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§ 868.5610 Membrane lung for long-term pulmonary support.

(a) Identification. A membrane lung for long-term pulmonary support is a device used to provide to a patient extracorporeal blood oxygenation for longer than 24 hours.

(b) Classification. Class III (premarket approval).

(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See § 868.3.

[47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987]

§ 868.5620 Breathing mouthpiece.

(a) 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.

(b) Classification. Class I (general controls).

§ 868.5630 Nebulizer.

(a) Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered

directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

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

§ 868.5640 Medicinal nonventilatory nebulizer (atomizer).

(a) 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.

(b) Classification. Class I (general controls).

§ 868.5650 Esophageal obturator.

(a) Identification. An esophageal obturator is a device inserted through a patient'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 closedend semirigid esophageal tube that is attached to a face mask.

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

§ 868.5655 Portable liquid oxygen unit.

(a) 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.

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

§ 868.5665 Powered percussor.

(a) Identification. A powered percussor is a device that is intended to transmit vibration through a patient'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.

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

§ 868.5675 Rebreathing device.

(a) 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.

(b) Classification. Class I (general controls). If the device is not labeled or otherwise represented as sterile, it is exempt from the good manufacturing practice regulation in Part 820, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

§ 868.5690 Incentive spirometer.

(a) Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation. (b) Classification. Class II (performance standards).

8868.5700 Nonpowered oxygen tent.

(a) Identification. A nonpowered oxygen tent is a device that encloses a patient's head and upper body to contain oxygen delivered to the patient for breathing. This generic type of device includes infant oxygen hoods.

(b) Classification. Class I (general controls).

§ 868.5710 Electrically powered oxygen tent.

(a) Identification. An electrically powered oxygen tent is a device that encloses a patient'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.

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

§ 868.5720 Bronchial tube.

(a) Identification. A bronchial tube is a device used to differentially intubate a patient'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.

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

§ 868.5730 Tracheal tube.

(a) Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

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

8868.5740 Tracheal/bronchial differential ventilation tube.

(a) Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.

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

§ 868.5750 Inflatable tracheal tube cuff.

(a) Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.

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

8868.5760 Cuff spreader.

(a) Identification. A cuff spreader is a device used to install tracheal tube cuffs on tracheal or tracheostomy tubes.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in Subpart E of Part 807 of this chapter. If the device is not labeled or otherwise represented as sterile, it is 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]

8868.5770 Tracheal tube fixation device.

(a) 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.

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

§ 868.5780 Tube introduction forceps.

(a) 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's trachea.

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

§ 868.5790 Tracheal tube stylet.

(a) Identification. A tracheal tube stylet is a device used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.

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

§ 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.

(b) Classification. Class II. [51 FR 40389, Nov. 6, 1986]

§ 868.5810 Airway connector.

(a) Identification. An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.

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

§ 868.5820 Dental protector.

(a) Identification. A dental protector is a device intended to protect a patient's teeth during manipulative procedures within a patient's oral cavity. (b) Classification. Class II (performance standards).

§ 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 II (performance standards).

§ 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

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(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 II (performance standards).

8 868.5995 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 II (perfomance standards).

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]

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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]

§ 868.6250 Portable air compressor.

(a) 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.

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

§ 868.6400 Calibration gas.

(a) Identification. A calibration gas is a device consisting of a container of gas of known concentration intended to calibrate medical gas concentration measurement devices.

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

§ 868.6700 Anesthesia stool.

(a) Identification. An anesthesia stool is a device intended for use as a stool for the anesthesiologist in the operating room.

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