Data / Medical devices / Tracheobronchial Suction Catheter Kit
Tracheobronchial Suction Catheter Kit (OFR): 18 FDA-registered makers in 3 countries
18 establishments in 3 countries are registered with the FDA to make Tracheobronchial Suction Catheter Kit (product code OFR, Class 1, 21 CFR 868.6810). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 7 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- OFR
- Device class
- 1
- Regulation
- 868.6810
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| China | 6 |
| United States | 6 |
| Mexico | 6 |
Makers of Tracheobronchial Suction Catheter Kit
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 |
|---|---|---|---|---|---|---|---|---|
| Allmed Medical Products Co., Ltd. | Zhijiang City Hubei, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allmed Medical Products Co., Ltd. | ZHIJIANG CITY Hubei, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amsino Medical (kunshan) Co., Ltd. | KUNSHAN CITY Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Centurion Medical Products, LP | Williamston, MI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health 200, LLC | El Paso, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Convertors de Mexico S. de R.L. de C.V | CD.JUAREZ Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Hong De Medical Plastic Products Co. Ltd. | Dongguan Guangdong, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Laredo | Laredo, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 7 | 1 | api.fda.gov | |
| Medline Industries, LP - SPT | Waukegan, IL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline Industries, LP - Mexicali (MXC) | Mexicali Baja California, Mexico | Contract sterilizer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline Soluciones Medicas | Nuevo Laredo Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Medline S.A. De C.V. | NUEVO LAREDO Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | SUZHOU Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tri-State De Mexico, S. De R.L. De C.V. | MEXICALI Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical de Tecate, S. de R.L de C.V. | TECATE Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Baite Medical Appliances Co., Ltd. | Huzhou City Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.