Bougie, Eustachian

Which Manufacturers in China Make This?

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

Gcmedica Enterprise Ltd.(Wuxi) Jiangsu, contract manufacturer
Hitec Medical Co., Ltd. Shanghai, contract manufacturer

What Is FDA Product Code KBI?

Bougie, Eustachian is FDA product code KBI, Class 1, 21 CFR 874.4175.

How Does It Reach the US Market?

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.

Bougie, Eustachian

Resp-O2 Endotracheal Tube Introducer (Bougie), Pediatric, 10 FR

Catalogue number 36260, listed by Dynarex Corp., United States, under Bougie, Eustachian. 2 manufacturers in China are registered for this product code.

Bougie, Eustachian

Resp-O2 Endotracheal Tube Introducer (Bougie), Adult, 15 FR

Catalogue number 36261, listed by Dynarex Corp., United States, under Bougie, Eustachian. 2 manufacturers in China are registered for this product code.

Bougie, Eustachian

Which Manufacturers in China Make This?

What Is FDA Product Code KBI?

How Does It Reach the US Market?

Resp-O2 Endotracheal Tube Introducer (Bougie), Pediatric, 10 FR

Resp-O2 Endotracheal Tube Introducer (Bougie), Adult, 15 FR

Where China Actually Supplies