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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR880]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
 
PART 880GENERAL HOSPITAL AND PERSONAL USE DEVICES
 

Subpart C--General Hospital and Personal Use Monitoring Devices

Sec. 880.2200 Liquid crystal forehead temperature strip.

(a)Identification. A liquid crystal forehead temperature strip is a device applied to the forehead that is used to indicate the presence or absence of fever, or to monitor body temperature changes. The device displays the color changes of heat sensitive liquid crystals corresponding to the variation in the surface temperature of the skin. The liquid crystals, which are cholesteric esters, are sealed in plastic.

(b)Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59228, Nov. 3, 1998]

Sec. 880.2400 Bed-patient monitor.

(a)Identification. A bed-patient monitor is a battery-powered device placed under a mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed.

(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 the limitations in 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001]

Sec. 880.2420 Electronic monitor for gravity flow infusion systems.

(a)Identification. An electronic monitor for gravity flow infusion systems is a device used to monitor the amount of fluid being infused into a patient. The device consists of an electronic transducer and equipment for signal amplification, conditioning, and display.

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

Sec. 880.2460 Electrically powered spinal fluid pressure monitor.

(a)Identification. An electrically powered spinal fluid pressure monitor is an electrically powered device used to measure spinal fluid pressure by the use of a transducer which converts spinal fluid pressure into an electrical signal. The device includes signal amplification, conditioning, and display equipment.

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

Sec. 880.2500 Spinal fluid manometer.

(a)Identification. A spinal fluid manometer is a device used to measure spinal fluid pressure. The device uses a hollow needle, which is inserted into the spinal column fluid space, to connect the spinal fluid to a graduated column so that the pressure can be measured by reading the height of the fluid.

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

Sec. 880.2700 Stand-on patient scale.

(a)Identification. A stand-on patient scale is a device intended for medical purposes that is used to weigh a patient who is able to stand on the scale platform.

(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 the limitations in 880.9. The device also 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.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38803, July 25, 2001]

Sec. 880.2720 Patient scale.

(a)Identification. A patient scale is a device intended for medical purposes that is used to measure the weight of a patient who cannot stand on a scale. This generic device includes devices placed under a bed or chair to weigh both the support and the patient, devices where the patient is lifted by a sling from a bed to be weighed, and devices where the patient is placed on the scale platform to be weighed. The device may be mechanical, battery powered, or AC-powered and may include transducers, electronic signal amplification, conditioning and display equipment.

(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 the limitations in 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001]

Sec. 880.2740 Surgical sponge scale.

(a)Identification. A surgical sponge scale is a nonelectrically powered device used to weigh surgical sponges that have been used to absorb blood during surgery so that, by comparison with the known dry weight of the sponges, an estimate may be made of the blood lost by the patient during surgery.

(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 the limitations in 880.9. The device also 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.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001]

Sec. 880.2800 Sterilization process indicator.

(a)Biological sterilization process indicator --(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.

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

(b)Physical/chemical sterilization process indicator --(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.

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

Sec. 880.2900 Clinical color change thermometer.

(a)Identification. A clinical color change thermometer is a disposable device used to measure a patient's oral, rectal, or axillary (armpit) body temperature. The device records body temperature by use of heat sensitive chemicals which are sealed at the end of a plastic or metal strip. Body heat causes a stable color change in the heat sensitive chemicals.

(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 the limitations in 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38804, July 25, 2001]

Sec. 880.2910 Clinical electronic thermometer.

(a)Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

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

Sec. 880.2920 Clinical mercury thermometer.

(a)Identification. A clinical mercury thermometer is a device used to measure oral, rectal, or axillary (armpit) body temperature using the thermal expansion of mercury.

(b)Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59228, Nov. 3, 1998]

Sec. 880.2930 Apgar timer.

(a)Identification. The Apgar timer is a device intended to alert a health care provider to take the Apgar score of a newborn infant.

(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 the limitations in 880.9. The device is also exempt from the current good manufacturing practice requirements in part 820 of this chapter, with the exception of 820.180 of this chapter, with respect to general requirements concerning records, and 820.198 of this chapter, with respect to complaint files.

[63 FR 59718, Nov. 5, 1998]

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.

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