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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: 21CFR884.6120]
See Related Information on Assisted reproduction accessories. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 884 -- OBSTETRICAL AND GYNECOLOGICAL DEVICES

Subpart G--Assisted Reproduction Devices

Sec. 884.6120 Assisted reproduction accessories.

(a)Identification. Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:

(1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova).

(2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures.

(3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation.

(4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature.

(5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature.

(b)Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing).

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