FDA.reportPublic FDA data

BurnFree

Primary DI
00743537000005
Brand
BurnFree
Company
WATER-JEL TECHNOLOGIES, L.L.C.
Model
SB-183152.00.000
Catalog number
SB-183152.00.000
Device description
"BurnFree 72""X60"", 183x152cm Fire/Trauma Blanket"
Published
2024-10-17
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
FPYSheet, Burn

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPYSheet, BurnGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00743537000005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00743537000005007435370000057435370000050743537000005

GMDN Terms#

Term, Definition table
TermDefinition
Pure wool burn sheetA covering designed to treat large to massive patient burns made of pure new woven wool impregnated with wound gel (e.g., hydrogel) and 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., towel to blanket (sheet)] and may also be used to smother small flames. 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
155522589
Device count
1
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196756544MEDLINEMEDLINE INDUSTRIES, INC.FPY2025-10-22
20197344112262MEDLINEMEDLINE INDUSTRIES, INC.FPY2024-11-08
10197344112265MEDLINEMEDLINE INDUSTRIES, INC.FPY2024-11-08
00743537000067First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000074First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000081First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000128First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000135First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000166First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000197First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000203First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537001439First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000029MilitaryWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000036First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000043First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000517First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000111MilitaryWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000531First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000548First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000555First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000050BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-19
00743537000012BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-17
10850053289528SURGYCOSurgyco LLCFPY2024-08-09
10850053289597SURGYCOSurgyco LLCFPY2024-08-09
10850053289603SURGYCOSurgyco LLCFPY2024-08-09
10850053289610SURGYCOSurgyco LLCFPY2024-08-09
00850053289521SURGYCOSurgyco LLCFPY2024-08-09
00850053289590SURGYCOSurgyco LLCFPY2024-08-09
00850053289606SURGYCOSurgyco LLCFPY2024-08-09
00850053289613SURGYCOSurgyco LLCFPY2024-08-09