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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, 2012]
[CITE: 21CFR870.4300]
 See Related Information on 870.4300 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 870 -- CARDIOVASCULAR DEVICES

Subpart E--Cardiovascular Surgical Devices

Sec. 870.4300 Cardiopulmonary bypass gas control unit.

(a)Identification. A cardiopulmonary bypass gas control unit is a device used to control and measure the flow of gas into the oxygenator. The device is calibrated for a specific gas.

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