FDA.reportPublic FDA data

First Responder Food Service Burn Kit 5/Case

Primary DI
M689FSKHA00020
Brand
First Responder Food Service Burn Kit 5/Case
Company
Safeguard US Operating, LLC
Model
02
Catalog number
FSK-HA.00
Device description
This kit offers a versatile combination of Burn Dressings, Burn Wrap/Fire Blankets and Burn Jel to meet emergency burn care needs in all resource limited settings (RLS) to better meet the different work environments of emergency medical and rescue first responders. It is designed and intended for use by emergency medical, rescue and non-medical personnel.
Published
2025-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
OJJBurn Kit Without Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJJBurn Kit Without DrugGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M689FSKHA00020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Burn kit, non-medicatedA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118492643
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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