BurnFree

Basic Information

• Brand Name: BurnFree
• Primary DI: 00743537000838
• Version / Model: SDI1000.00.000
• Catalog Number: SDI1000.00.000
• Company Name: WATER-JEL TECHNOLOGIES, L.L.C.
• Labeler DUNS: 155522589
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2024-11-01
• Public Version: 1
• Public Version Date: 2024-11-11
• Public Version Status: New
• Public Device Record Key: 83a34b43-38d9-4493-b4af-d009be91b7c9

Device Description

BurnFree SD, 3.5g 1,000/cs; BD Gel

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
47694	Burn gel	A substance intended to be applied directly to a minor burn or sunburn to protect against infection, minimize trauma and skin damage, moisten and cool the burn area, and prevent burn progression. It is typically available in sachets, bottles, or spray containers as a gel or spray and is used by emergency medical services (EMS) and critical care units, but may also be used in the home. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00743537000821	GS1
Primary	00743537000838	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K990180	000