PEF

Heparin Flush In 0.45% Sodium Chloride

Product code

PEF

Device name

Heparin Flush In 0.45% Sodium Chloride

Device class

Class 2

21 CFR

21 CFR 880.5200

Medical specialty

General Hospital

Marketing pathway

510(K)

FDA classification definition

The heparin flush in 0.45% sodium chloride is intended to maintain patency of an indwelling intravenous catheter device designed for intermittent injection or infusion therapy or blood sampling. It provides an alternative to clinicians to prevent sodium overload in neonatal patients.

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