PEV

Dialysis Administration Kit

Product code

PEV

Device name

Dialysis Administration Kit

Device class

Class 2

21 CFR

21 CFR 876.5820

Medical specialty

Gastroenterology, Urology

Marketing pathway

Enforcement Discretion

FDA classification definition

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

Definition text from the FDA device classification database (U.S. federal government work, public domain).