BURNSHIELD

Basic Information

• Brand Name: BURNSHIELD
• Primary DI: 06007645001540
• Version / Model: 550013
• Catalog Number: 550013
• Company Name: BURNSHIELD (PTY) LTD
• Labeler DUNS: 635842958
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-25
• Public Version: 2
• Public Version Date: 2021-08-24
• Public Version Status: Update
• Public Device Record Key: 3fc6b08d-eec6-4fd1-8558-db64e516f741

Device Description

BURNSHIELD MINI BURN KIT

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: No
• 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: Yes
• 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
47693	Synthetic polymer burn dressing, gel-coated	A sterile covering designed to treat small to large patient burns. It is made from synthetic polymer material impregnated with wound gel (e.g., hydrogel) and is 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., 10x10 cm to 60x40 cm) and may be body contoured; it is also available in prefabricated shapes (e.g., face mask). 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
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
Package	36007645001541	GS1	BOX	100	In Commercial Distribution
Primary	06007645001540	GS1
Package	06007645002035	GS1	BOX	6	In Commercial Distribution
Package	26007645001544	GS1	BOX	16	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K943728	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 40 Degrees Celsius