Data / Medical devices / Tube, Double Lumen For Intestinal Decompression And/Or Intubation
Tube, Double Lumen For Intestinal Decompression And/Or Intubation (FEG): 13 FDA-registered makers in 4 countries
13 establishments in 4 countries are registered with the FDA to make Tube, Double Lumen For Intestinal Decompression And/Or Intubation (product code FEG, Class 2, 21 CFR 876.5980). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on August 1, 2017, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FEG
- Device class
- 2
- Regulation
- 876.5980
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| China | 4 |
| Mexico | 3 |
| Ireland | 1 |
Makers of Tube, Double Lumen For Intestinal Decompression And/Or Intubation
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 |
|---|---|---|---|---|---|---|---|---|
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 2 | May 17, 2004 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health (Kenmex Medical Specialties) | TIJUANA Baja California, Mexico | Manufacturer | 2 | May 17, 2004 | 0 | 0 | 0 | api.fda.gov |
| Axiom Medical, Inc. | Torrance, CA, United States | Manufacturer | 1 | July 19, 1977 | 0 | 0 | 0 | api.fda.gov |
| C.R. Bard, Inc. | Covington, GA, United States | Manufacturer | 1 | July 24, 1996 | 0 | 1 | 0 | api.fda.gov |
| Cook Ireland Ltd | LIMERICK Limerick(County), Ireland | Complaint file establishment, Manufacturer | 1 | August 1, 2017 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 1 | September 18, 2013 | 0 | 0 | 0 | api.fda.gov |
| Allwin Medical Devices, Inc. | Anaheim, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | TIJUANA, B.C. Mexico, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Caina Medical Co., Ltd | Jiangyin Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Tianyi Medical Appliance CO., Ltd. | Ningbo Zhejiang, China | Contract manufacturer, Contract sterilizer | 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 | |
| Well Lead Medical Co. Ltd | GUANGZHOU Guangdong, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Well Lead Medical Co. Ltd | GUANGZHOU Guangdong, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 1, 2017. 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.