FDA.reportPublic FDA data

BurnFree

Primary DI
00743537000227
Brand
BurnFree
Company
WATER-JEL TECHNOLOGIES, L.L.C.
Model
051560.00.000
Catalog number
051560.00.000
Device description
"BurnFree 5cm x 15cm (2""X6"") Burn Dressing 60/cs; BD Gel"
Published
2024-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00743537000227PrimaryGS10
00743537000173Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00743537000227007435370002277435370002270743537000227
00743537000173007435370001737435370001730743537000173

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.

Contacts#

Phone, Email table
PhoneEmail
855-428-6074sales@safeguardmedical.com

Regulatory Flags#

DUNS number
155522589
Device count
60
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00743537000456First ResponderB1216-20.00.000B1216-20.00.0002026-02-19
00743537000470MilitaryWJ30HA.00.000WJ30HA.00.0002026-02-19
00743537000449First ResponderB1216-20.00.000B1216-20.00.0002026-02-19
00743537000715MilitaryWJ30HA.00.000WJ30HA.00.0002026-02-19
00743537000791BurnFreeSD25-24.00.000SD25-24.00.0002024-11-01
00743537000814BurnFreeSD6-100.00.000SD6-100.00.0002024-11-01
00743537000838BurnFreeSDI1000.00.000SDI1000.00.0002024-11-01
00743537000852Burn StopBSG350R.02.000BSG350R.02.0002024-11-01
00743537000876Water-JelGBJ140.02.000GBJ140.02.0002024-11-01
00743537000890Water-JelGBJ140G.19.000GBJ140G.19.0002024-11-01
00743537000913Water-JelGCJ140G.40.000 GCJ140G.40.000 2024-11-01
00743537000937Water-JelCJ25-600.00.000CJ25-600.00.0002024-11-01
00743537000951Water-JelCJ25-600.24.000CJ25-600.24.0002024-11-01
00743537000975Burn StopCJ25-600.50.000CJ25-600.50.0002024-11-01
00743537000999Water-JelCJ25-600.69.000CJ25-600.69.0002024-11-01
00743537001019Water-JelCJ6-600.00.000CJ6-600.00.0002024-11-01
00743537001033Water-JelCJ6-600.24.000CJ6-600.24.0002024-11-01
00743537001057Water-JelCJ-BULK.00.000CJ-BULK.00.0002024-11-01
00743537001071Burn StopCJ-BULK.50.000CJ-BULK.50.0002024-11-01
00743537001095Water-JelCJ-BULK.77.000CJ-BULK.77.0002024-11-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10840330704943ProCureTwin Med, LLCNAE2026-04-22
10840330705803ProCureTwin Med, LLCNAE2026-04-22
10840330705810ProCureTwin Med, LLCNAE2026-04-22
10840330706350ProCureTwin Med, LLCNAE2026-04-22
00324357010155Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00324357100252Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00324357104045Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00743537000456First ResponderWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
00743537000470MilitaryWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
10197344017508MEDLINEMEDLINE INDUSTRIES, INC.NAE2025-10-23
00858071004478Natural Shield Wound Dressing, 1oz brush onKericure Inc.NAE2025-10-06
00858071004553Natural Shield Wound Dressing, 1oz sprayKericure Inc.NAE2025-10-06
20192253040156KendallCardinal Health 200, LLCNAE2025-09-26
00197998326882Solventum™ Nu-Gel™Solventum Germany GmbHNAE2025-09-22
00197998326967Solventum™ Nu-Gel™Solventum Germany GmbHNAE2025-09-22
15056860000034Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
15056860000041Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
15056860000058Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
10197344110162MEDLINEMEDLINE INDUSTRIES, INC.NAE2025-08-04
06974600043672KONLIDASuzhou Konlida Medical Supplies Co., Ltd.NAE2025-07-28
M689HHWSK02050Wound Seal KitSafeguard US Operating, LLCNAE2025-06-24
06971292003694AUVONShenzhen Yuwen E-Commerce Co., Ltd.NAE2025-06-19
06971292003700AUVONShenzhen Yuwen E-Commerce Co., Ltd.NAE2025-06-19
00810040134692SimpuritySAFE N' SIMPLE LLCNAE2025-06-17
00810040134708SimpuritySAFE N' SIMPLE LLCNAE2025-06-17
00361554005614GentellGentell, LLCNAE2025-02-14
00361554005638GentellGentell, LLCNAE2025-02-14