First Responder

Basic Information

• Brand Name: First Responder
• Primary DI: 00743537000081
• Version / Model: G3630P-4.24.000
• Catalog Number: G3630P-4.24.000
• Company Name: WATER-JEL TECHNOLOGIES, L.L.C.
• Labeler DUNS: 155522589
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2024-10-25
• Public Version: 1
• Public Version Date: 2024-11-04
• Public Version Status: New
• Public Device Record Key: 5e938301-0458-4b59-acda-a94b497cd492

Device Description

First Responder Burn Wrap 3'x2.5', 4 Pouches/cs, Canada; BD Gel HA

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: Yes
• 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
FPY	Sheet, Burn	General Hospital	880.5180	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47696	Pure wool burn sheet	A covering designed to treat large to massive patient burns made of pure new woven wool impregnated with wound gel (e.g., hydrogel) and applied over the burn to protect against infection, minimize trauma and skin damage, moisten and cool the burn area, and prevent burn progression. It is available in various sizes [e.g., towel to blanket (sheet)] and may also be used to smother small flames. It is typically used by emergency medical services (EMS) and critical care units, but may also be used in the home. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00743537000517	GS1
Primary	00743537000081	GS1

Customer Contacts

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