
Puritas Health Care, Inc.
Free shipping on orders over $99 · 30-day returns
URINARY DRAINAGE BAG is an FDA 510(k)-cleared medical device (K935557) manufactured by Puritas Health Care, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 6, 1994. Regulation: 8.