Burnshield

Basic Information

• Brand Name: Burnshield
• Primary DI: 00198168620991
• Version / Model: BUREBK-3-RB
• Catalog Number: BUREBK-3-RB
• Company Name: Burnshield Usa, LLC
• Labeler DUNS: 066750751
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-21
• Public Version: 1
• Public Version Date: 2023-11-29
• Public Version Status: New
• Public Device Record Key: 3dd24897-a665-4b41-94f8-f5f768fad8b2

Device Description

Burnshield Large Burn Kit - BUREBK-3-RB

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: Yes
• 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
OJJ	Burn Kit Without Drug	General, Plastic Surgery	878.4022	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10516	Burn kit, non-medicated	A collection of devices designed to treat first or second degree burns typically as first aid therapy by emergency medical services (EMS); it does not include pharmaceuticals. It typically includes burn dressings, burn gels, gauze, cold packs, adhesive tapes, and gloves; it may include additional devices such as scissors and masks. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10198168620998	GS1	CASE	5	In Commercial Distribution
Primary	00198168620991	GS1

Customer Contacts

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