Data / Medical devices / Bottle, Collection And Trap, Breathing System (Uncalibrated)
Bottle, Collection And Trap, Breathing System (Uncalibrated) (CBC): 12 FDA-registered makers in 6 countries
12 establishments in 6 countries are registered with the FDA to make Bottle, Collection And Trap, Breathing System (Uncalibrated) (product code CBC, Class 2, 21 CFR 880.6740). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on May 13, 1993, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- CBC
- Device class
- 2
- Regulation
- 880.6740
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| Germany | 3 |
| Hong Kong | 2 |
| China | 2 |
| United States | 2 |
| Mexico | 2 |
| Turkey | 1 |
Makers of Bottle, Collection And Trap, Breathing System (Uncalibrated)
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 |
|---|---|---|---|---|---|---|---|---|
| Ga Health Company Limited | Hong Kong, Hong Kong | Complaint file establishment, Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | NEUHAUSEN OBECK Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Megasan Medikal Gaz Sistemleri Tibbi Alet Ve Cihazlar San. Tic. A. S. | Cankiri, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smartdata Suzhou Co., Ltd | Suzhou Jiangsu, China | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| SML Med-Tech Solutions Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WESTMED de Mexico, S.A de C.V. | Tecate Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westmed, Inc. | Tucson, AZ, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westmed Javid de Mexico, S.A. de C.V. | NOGALES Sonora, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yuyao Jiahua Medical Appliance, Co., Ltd. | Yuyao Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 13, 1993. 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.