Data / Medical devices / United States / Carowinds
Carowinds: FDA-registered device maker in Charlotte, NC, United States, 1 510(k) clearance
Carowinds is registered with the FDA (registration 3024971708) in Charlotte, NC, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 11, 2001. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024971708
- Address
- Ste A 13327 Carowinds Blvd, Charlotte, NC, United States, 28273
- Owner or operator
- Productiv, Inc (10086303)
- Roles
- Repackager or relabeler
- First device listed
- October 28, 2022
- Registered through
- 2026
- Brand names listed
- Burnfree SD, Cool Jel Unit Dose, NAR Bleeding Control Kit, Prostat Burn Stop, WJ Burn Stop
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | U | Repackager or relabeler | accessdata.fda.gov |
| First Aid Kit Without Drug | OHO | 1 | 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 |
|---|---|---|---|---|---|---|
| January 11, 2001 | K003396 | BURN JEL PLUS | MGQ | Substantially Equivalent | Water-Jel Technologies, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- All makers of First Aid Kit Without Drug
Updated January 11, 2001. 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.