FDA.reportPublic FDA data

Water-Jel

Primary DI
00743537000876
Brand
Water-Jel
Company
WATER-JEL TECHNOLOGIES, L.L.C.
Model
GBJ140.02.000
Catalog number
GBJ140.02.000
Device description
Burn Jel HA Unit Dose 1728/cs for WJE; BD Gel HA
Published
2024-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00743537000876PrimaryGS10
00743537000869Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00743537000876007435370008767435370008760743537000876
00743537000869007435370008697435370008690743537000869

GMDN Terms#

Term, Definition table
TermDefinition
Burn gelA 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.

Contacts#

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

Regulatory Flags#

DUNS number
155522589
Device count
1728
Premarket exempt
true
Lot or batch
true
Expiration date on label
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
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
00743537000784BurnFreeSD25-24.00.000SD25-24.00.0002024-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10840330704936ProCureTwin Med, LLCNAE2026-04-22
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