Water-Jel Technologies, LLC

FDA Device Registration & Listing · Huntersville, NC, US · Registration 1219592

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1219592
FEI Number
1219592
Entity Name
Water-Jel Technologies, LLC
City/State/Country
Huntersville, NC, US
Establishment Address
13359 Reese Blvd. E, Huntersville, NC 28078, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Safeguard US Holdco INC (Owner Number: 1219592)
Owner / Operator Contact Address
13359 Reese Blvd. E, Huntersville, NC 28078, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K800064
PMA Number
N/A

All Registered Proprietary Names

Water-Jel First Responder HA Water-Jel Military Water-Jel Tactical BurnFree Burn Jel Plus Cool Jel Wound Gel Water-Jel First Responder Water-Jel Tactical

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FPY Sheet, Burn General Hospital Class 1 880.5180 2016-10-20
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Unknown Class U N/A 2007-10-27
FPY Sheet, Burn General Hospital Class 1 880.5180 2007-10-27

Official Correspondent

Kimberly Reed

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Safeguard US Holdco 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 ***Sterile***Manufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA***

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1219592. Last updated year: 2026. Please use registration number 1219592 when referencing this establishment in official correspondence.
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