Bag, Bile Collecting

Which Manufacturers in China Make This?

One manufacturer in China holds an FDA registration for this device type, based in Jiangsu.

Suzhou Meccan Import and Export Corp. Jiangsu, contract manufacturer

How Is EXF Classified?

Bag, Bile Collecting is FDA product code EXF, Class 2, 21 CFR 876.5010.

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.

What Do the Recalls Say?

The FDA has recorded 3 recalls under this product code since 2007. None was by a company in China. The root causes the FDA records most often are Process control (1) and Labeling mix-ups (1).

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

Bag, Bile Collecting

Drainage Bag

Size: 600 ml

Bag, Bile Collecting

VacuBag

Catalogue number NDB1000, listed by Bard Access Systems, Inc., United States, under Bag, Bile Collecting. 1 manufacturer in China is registered for this product code.

Bag, Bile Collecting

Navarre

Bard Navarre Universal Gravity Drainage Bag

Bag, Bile Collecting

Merit Drainage Depot™

4 catalogue numbers from 00884450008256, listed by Merit Medical Systems, Inc., United States, under Bag, Bile Collecting. 1 manufacturer in China is registered for this product code.

Bag, Bile Collecting