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support and anchor a patient's breathing tube(s).

(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]

gases that are to be breathed by a patient.

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

8868.5300 Carbon dioxide absorbent.

(a) Identification. A carbon dioxide absorbent is a device intended for med· ical purposes that consists of an absorbent material (e.g., soda lime) that is intended to remove carbon dioxide from the gases in the breathing circuit.

(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]

$868.5340 Nasal oxygen cannula.

(a) Identification. A nasal oxygen cannula is a two-pronged device used to administer oxygen to a patient through both nostrils.

(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 59 FR 63007, Dec. 7, 1994)

$868.5350 Nasal oxygen catheter.

(a) Identification. A nasal oxygen catheter is a device intended to be inserted through a patient's nostril to administer oxygen.

(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 59 FR 63007, Dec. 7, 1994]

8 868.5310 Carbon dioxide absorber.

(a) Identification. A carbon dioxide absorber is a device that is intended for medical purposes and that is used in a breathing circuit as a container for carbon dioxide absorbent. It may include a canister and water drain.

(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)

8 868.5365 Posture chair for cardiac or

pulmonary treatment. (a) 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.

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

8868.5320 Reservoir bag.

(a) 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's ventilation.

(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)

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

$ 868.5375 Heat and moisture

con. denser (artificial nose). (a) Identification. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.

$868.5330 Breathing gas mixer.

(a) Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of

$ 820.198, with respect to complaint files.

(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)

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

$868.5430 Gas-scavenging apparatus.

(a) Identification. A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system.

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

$868.5400 Electroanesthesia appa

ratus. (a) 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's head.

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

(c) Date PMA or notice of completion of a PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any electroanesthesia apparatus that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to electroanesthesia apparatus that was in commercial distribution before May 28, 1976. Any other electroanesthesia apparatus shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

8868.5440 Portable oxygen generator.

(a) 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).

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

an

8868.5450 Respiratory gas humidifier.

(a) Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.

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

[47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 61 FR 50706, Sept. 27, 1996)

$ 868.5420 Ether hook.

(a) Identification. An ether hook is a device that fits inside a patient's mouth and that is intended to deliver vaporized ether.

(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 8 820.180, with respect to general requirements concerning records, and

$ 868.5460 Therapeutic humidifier for

home use. (a) 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.

(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; 47 FR 40410, Sept. 14, 1982, as amended at 61 FR 1120, Jan. 16, 1996)

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

(47 FR 41107, Sept. 17, 1982, as amended at 54 FR 25048, June 12, 1989)

$868.5470 Hyperbaric chamber.

(a) 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's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (8 878.5650).

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

8 868.5570 Nonrebreathing mask.

(a) Identification. A nonrebreathing mask is a device fitting over a patient's face to administer oxygen. It utilizes one-way valves to prevent the patient from rebreathing previously exhaled 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]

8868.5530 Flexible laryngoscope.

(a) Identification. A flexible laryngoscope is a fiberoptic device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [47 FR 41107, Sept. 17, 1982, as amended at 61 FR 1120, Jan. 16, 1996) $868.5540 Rigid laryngoscope.

(a) Identification. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [47 FR 41107, Sept. 17, 1982, as amended at 61 FR 1120, Jan. 16, 1996)

$868.5580 Oxygen mask.

(a) Identification. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.

(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)

$868.5550 Anesthetic gas mask.

(a) 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.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (47 FR 41107, Sept. 17, 1982, as amended at 61 FR 1120, Jan. 16, 1996)

$ 868.5590 Scavenging mask.

(a) Identification. A scavenging mask is a device positioned over a patient'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.

(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)

8868.5560 Gas mask head strap.

(a) Identification. A gas mask head strap is a device used to hold an anesthetic gas mask in position on a patient's face.

$ 868.5600 Venturi mask.

(a) 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.

(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 E of part 807 of this chapter subject to $868.9. [47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000)

$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

closed-end semirigid esophageal tube that is attached to a face mask.

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

$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)

a

$ 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). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $ 868.9. [47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000)

$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).

$868.5630 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).

$868.5665 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).

or

$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). The device is exempt from the premarket notification procedures in

$ 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 for increasing minute ventilation.

(b) 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. [47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000)

8868.5690 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).

8868.5740 Trachealbronchial differen

tial 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).

$868.5700 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). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $868.9. (47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000)

$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).

8868.5710 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).

$ 868.5760 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)

$ 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).

$868.5770 Tracheal tube fixation de

vice. (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 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)

8868.5730 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).

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