Gas, Collecting Vessel

Which Manufacturers in China Make This?

2 manufacturers in China hold an FDA registration for this device type, based in Fujian and Hubei. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

GaleMed (Xiamen) Co., Ltd. Fujian, contract manufacturer
Hubei V-Medical Products Co., Ltd. Hubei, contract manufacturer

What Is FDA Product Code KGK?

Gas, Collecting Vessel is FDA product code KGK, Class 1, 21 CFR 868.1575.

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.

Gas, Collecting Vessel

Syringe

Catalogue number QT02741, listed by Quintron Instrument Co., Inc., United States, under Gas, Collecting Vessel. 2 manufacturers in China are registered for this product code.

Gas, Collecting Vessel