Data / Medical devices / United States / CBX LLC
CBX LLC: FDA-registered device maker in Carlsbad, CA, United States, 2 510(k) clearances
CBX LLC is registered with the FDA (registration 3030455652) in Carlsbad, CA, United States. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 22, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030455652
- Address
- 2777 Loker Ave W, Suite C, Carlsbad, CA, United States, 92010
- Owner or operator
- CBX LLC (10061645)
- Roles
- Repackager or relabeler
- First device listed
- November 5, 2019
- Registered through
- 2026
- Brand names listed
- TRUE RESCUE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Repackager or relabeler | accessdata.fda.gov |
| First Aid Kit Without Drug | OHO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Valve, Non-Rebreathing | CBP | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 22, 2010 | K083418 | CPR MASK | CBP | Substantially Equivalent | Firstar Healthcare Co., Ltd. | accessdata.fda.gov |
| February 26, 2002 | K020493 | SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | Syntex Healthcare Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Gauze/Sponge, Internal, X-Ray Detectable
- All makers of Dressing, Wound, Hydrophilic
- All makers of Mouthpiece, Breathing
- All makers of First Aid Kit Without Drug
- All makers of Valve, Non-Rebreathing
- All makers of Bandage, Elastic
Updated July 22, 2010. 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.