FDA.reportPublic FDA data

Water-Jel

Primary DI
00743537001040
Brand
Water-Jel
Company
WATER-JEL TECHNOLOGIES, L.L.C.
Model
CJ-BULK.00.000
Catalog number
CJ-BULK.00.000
Device description
Cool Jel unit dose 1728 pcs bulk per case; Cool Jel
Published
2024-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
00743537001057PrimaryGS10
00743537001040Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00743537001057007435370010577435370010570743537001057
00743537001040007435370010407435370010400743537001040

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
155522589
Device count
1728
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00743537000753Military7260-MP.00.0007260-MP.00.0002026-10-30
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
00743537001408Water-JelCJ4-24.24.000CJ4-24.24.0002024-10-29
00743537001415Water-JelCJ4-24.50.000CJ4-24.50.0002024-10-29
00743537001422Water-JelCJ2-24.00.000CJ2-24.00.0002024-10-29
00743537001118BurnFree120B24.00.000120B24.00.0002026-10-05
00743537001224BurnFree60B48.00.00060B48.00.0002026-10-05
00743537001231BurnFreeBSG50.02.000BSG50.02.0002026-10-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00370275900801PerioStomForward Science Technologies LLCMGQ2026-08-07
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
00743537001071Burn StopWATER-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