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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device clamp, dialysis arm
Regulation Description Blood access device and accessories.
Definition The device is a clamp used to close off needle holes in the arm of a Dialysis patient. The clamp applies uniform pressure to the sites of needle holes in the patient's arm until the holes close. The clamp pressure is designed to stop bleeding without causing blood clots. This is a different type of device than those listed in the classification regulation.
Product CodeNOO
Regulation Number 876.5540
Device Class 1