FDA.reportPublic FDA data

Burn Stop

Primary DI
00743537001071
Brand
Burn Stop
Company
WATER-JEL TECHNOLOGIES, L.L.C.
Model
CJ-BULK.50.000
Catalog number
CJ-BULK.50.000
Device description
WJ Burn Stop Unit Dose 1728/cs; Cool Jel
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
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003396000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003396000BURN JEL PLUSWater-Jel Technologies, LLC2001-01-11MGQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00743537001071PrimaryGS10
00743537001064Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00743537001071007435370010717435370010710743537001071
00743537001064007435370010647435370010640743537001064

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
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
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
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
00368040753141Promiseb Topical CreamPrimus Pharmaceuticals, Inc.MGQ2026-05-01
00850058790114RV-X1Gel4med, Inc.MGQ2025-10-17
00850058790121RV-X1Gel4med, Inc.MGQ2025-10-17
00850058790138G4Derm PlusGel4med, Inc.MGQ2025-10-17
00850058790145G4Derm PlusGel4med, Inc.MGQ2025-10-17
00850058790152G4Derm PlusGel4med, Inc.MGQ2025-10-17
00383160000104Dash TopicAIM MEDICAL INC.MGQ2025-05-12
00850058790060SuprelloGel4med, Inc.MGQ2025-03-25
00850058790084SuprelloGel4med, Inc.MGQ2025-03-25
00850058790091SuprelloGel4med, Inc.MGQ2025-03-25
00860013569907MuGardSoleva Pharma LLCMGQ2025-02-28
00743537000791BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000814BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000838BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000852Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000913Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000937Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000951Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000975Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000999Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001019Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001033Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001057Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001095Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000784BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000807BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000821BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000845Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000906Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000920Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01