Bassinet, Hospital

What Is This Device?

Intended for medical purposes designed for the use of a pediatric patient made of all construction materials used in a hospital nursery.

How Is NZG Classified?

Bassinet, Hospital is FDA product code NZG, Class 2, 21 CFR 880.5145.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 2 recalls under this product code since 2011. None was by a company in China. The root cause the FDA records most often is Device Design (2).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.