Data / Medical devices / Bag, Bile Collecting
Bag, Bile Collecting (EXF): 14 FDA-registered makers in 3 countries
14 establishments in 3 countries are registered with the FDA to make Bag, Bile Collecting (product code EXF, Class 2, 21 CFR 876.5010). 3 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on December 11, 2000, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EXF
- Device class
- 2
- Regulation
- 876.5010
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Mexico | 3 |
| Dominican Republic | 2 |
Makers of Bag, Bile Collecting
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Argon Medical Devices Inc. | Athens, TX, United States | Contract manufacturer, Manufacturer | 1 | January 30, 1998 | 0 | 0 | 0 | api.fda.gov |
| Bard Access Systems, Inc. | Salt Lake City, UT, United States | Specification developer | 1 | September 8, 1994 | 0 | 0 | 0 | api.fda.gov |
| Remington Medical, Inc. | Alpharetta, GA, United States | Manufacturer | 1 | August 12, 1999 | 0 | 3 | 0 | api.fda.gov |
| C.R. Bard, Inc. | Queensbury, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C.R. Bard, Inc. | Covington, GA, United States | Contract sterilizer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marlen MFG. & Development Co. | Bedford, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microtek Dominicana, S.A.S. | La Romana, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Maquiladora Mexico, S. DE R.L. DE C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Para El Cuidado De La Salud | NOGALES Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remington Medical, S.A. | Santo Domingo Este, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterigenics U.S., LLC | Salt Lake City, UT, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Uresil, LLC | Skokie, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 11, 2000. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.