FDA.reportPublic FDA data

PrepEM Wild

Primary DI
06975675788581
Brand
PrepEM Wild
Company
EMSRUN GROUP
Model
Dry burn dressing/40*60cm
Published
2025-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975675788581PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975675788581069756757885816975675788581

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 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.

Regulatory Flags#

DUNS number
712452198
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975675784682Rhino RescueFirst Aid Kit/IFAK/R202026-06-01
06975675788093Rhino RescueFirst Aid Kit/CPIK0284/Red2026-06-01
06975675788109Rhino RescueFirst Aid Kit/CPIK02852026-06-01
06975675788123Rhino RescueFirst aid kit/CPIK0269/Red2026-02-09
16975675788120Rhino RescueFirst aid kit/CPIK0269/Red2026-02-09
06975675781490PrepEM Wild18in splint2025-11-07
06975675781650PrepEM WildWound plaster/15pcs2025-11-07
06975675781667PrepEM WildNon-woven tape/2.5cm*5m2025-11-07
06975675781711PrepEM WildNitrile gloves/L2025-11-07
06975675781759PrepEM WildEmergency blanket/1.6*2.1m2025-11-07
06975675781773PrepEM WildScissors/16cm2025-11-07
06975675782091PrepEM WildPBT bandage/7.5cm*4.5m2025-11-07
06975675783074PrepEM WildWound compress/10*10cm/2pcs2025-11-07
06975675783302PrepEM WildCompressed gauze z-fold2025-11-07
06975675788499StBernardFirst aid kit/STIK00082025-11-07
06975675788505StBernardFirst aid kit/STIK00072025-11-07
06975675788512StBernardFirst aid kit/STIK00062025-11-07
06975675788529StBernardFirst aid kit/STIK00052025-11-07
06975675788536StBernardFirst aid kit/STIK00042025-11-07
06975675788543StBernardFirst aid kit/STIK00032025-11-07

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05060483573083Russell Chest Seal - Twin (US Version)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDNAD2026-07-24
05060483570006Russell Chest Seal (US Version)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDNAD2026-07-20
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00850088144215CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
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00850088144253CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144000CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-03
00850088144017CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-03
00850087488686CeeportCEEPORT INC.NAD2026-06-30
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06970206828163Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206828170Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
00860015727343KegelStar Port IncNAD2026-06-12
00860015727350KegelStar Port IncNAD2026-06-12
10885632506000HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-06-05