PAD

Chest Drainage Kit

Product code

PAD

Device name

Chest Drainage Kit

Device class

Class 2

21 CFR

21 CFR 880.6740

Medical specialty

General Hospital

Marketing pathway

Enforcement Discretion

Flag

GMP exempt

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).