Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024971708

FEI Number

3024971708

Entity Name

Carowinds

City/State/Country

Charlotte, NC, US

Establishment Address

Ste A 13327 Carowinds Blvd, Charlotte, NC 28273, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Productiv, Inc (Owner Number: 10086303)

Owner / Operator Contact Address

Ste A 13327 Carowinds Blvd, Charlotte, NC 28273, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K003396

PMA Number

N/A

All Registered Proprietary Names

NAR Bleeding Control Kit Burnfree SD Cool Jel Unit Dose Prostat Burn Stop WJ Burn Stop

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2026-02-04
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2022-10-28

Official Correspondent

Marius Ailenei

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Productiv, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K954741	Derma Sciences, Inc.	DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)	1995-11-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-05	DeRoyal Wound Care	U	Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part *SterileManufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA**

Similar Registrations

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3042028938	Laurens WTC	Clinton, SC, US
3007329149	MAJESTIC AEROTECH, INC	Tacoma, WA, US
3009576895	FRIENDSHIP INDUSTRIES	Harrisonburg, VA, US
3005951296	Jiangsu Goju Identification Technology Co., Ltd.	YANCHENG CITY Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024971708. Last updated year: 2026. Please use registration number 3024971708 when referencing this establishment in official correspondence.