FDA.reportPublic FDA data

Uline Burn Kit - Single Use

Primary DI
10851253007691
Brand
Uline Burn Kit - Single Use
Company
ULINE, INC.
Model
H-4172
Catalog number
H-4172
Device description
"BURN GEL,FIRST AID FACTS GUIDE,FIRST AID TAPE,GAUZE BANDAGE COMPRESS,INSTANT ICE PACK,NITRILE GLOVES,NON-STICK PADS,1 X 3"" PLASTIC BANDAGES,2 X 3"" PLASTIC BANDAGES,RESCUE BLANKET,BURN DRESSING - 4 X 4"",BURN DRESSING - 8 X 8"""
Published
2019-01-18
Public version status
Update
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
LRRFirst Aid Kit With Drug
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRRFirst Aid Kit With DrugUnknownN
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851253007691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085125300769110851253007691

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic polymer burn dressing, gel-coatedA sterile covering designed to treat small to large patient burns. It is made of polyurethane impregnated with wound gel (e.g., hydrogel) and is applied over the burn to protect against infection, minimize trauma and skin damage, provide pain relief, 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
039612668
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850015055321ANSI First Aid Kit Class B+, 250 PersonH-99972022-03-22
10851253007905ANSI First Aid Kit Class B+H-87572020-01-30
10850015055833ULINE BLACK EXAM NITRILE GLVS-LS-21081-L2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MS-21081-M2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SS-21081-S2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XS-21081-X2026-07-14
10850015055871TOUGHGRIP 7 MIL LATEX GLOVES-LS-19177L2026-07-14
10850015055888TOUGHGRIP 7 MIL LATEX GLOVES-MS-19177M2026-07-14
10850015055895TOUGHGRIP 7 MIL LATEX GLOVES-SS-19177S2026-07-14
10850015055901TOUGHGRIP 7 MIL LATEX GLOVES-XS-19177X2026-07-14
10850015055918EXT CUFF 12 MIL LATEX GLOVES-LS-17904L2026-07-10
10850015055925EXT CUFF 12 MIL LATEX GLOVES-MS-17904M2026-07-10
10850015055932EXT CUFF 12 MIL LATEX GLOVES-SS-17904S2026-07-10
10850015055949EXT CUFF 12 MIL LATEX GLOVES-XS-17904X2026-07-10
10851253007622Uline First Aid Kit - 100 PersonH-3319H-33192019-01-18
10851253007639Uline First Aid Kit - 250 PersonH-3795H-37952019-01-18
10850015055826Trauma KitH-99542026-04-06
10850015055789ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, LARGES-12549L2025-04-28
10850015055796ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, MEDIUMS-12549M2025-04-28
10850015055802ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, SMALLS-12549S2025-04-28

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