FDA.reportPublic FDA data

TACWrap Multi-Purpose Burn Cravat

Primary DI
M689HHTWBC020
Brand
TACWrap Multi-Purpose Burn Cravat
Company
Safeguard US Operating, LLC
Model
02
Catalog number
HHTWBC
Device description
This dressing is sterile and non-adherent to be used as an emergency burn dressing when no access to clean water is found.
Published
2026-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
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
M689HHTWBC020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic polymer burn dressing, non-coatedA sterile covering designed to be applied over a burn typically in an emergency situation to prevent burn progression and protect against infection. It is available in various sizes (e.g., 10x10 cm to 60x90 cm), intended to treat small to large patient burns, and made of synthetic polymer materials and is not impregnate with a gel coating. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
118492643
Device count
1
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M68985201020Mojo Vehicle Rescue Bag - Basic0285-2012026-01-30
M6898723101030Bleeding Control Kit0387-231-012026-07-30
M689HHTWBC25010TACWrap Multi-Purpose Burn Cravat Case of 2501HHTWBC-252026-07-28
M6898810501060Patrol Officer IFAK Basic0688-105-012026-07-27
M6898810502060Patrol Officer IFAK Intermediate0688-105-022026-07-27
M6898810503070Patrol Officer IFAK Advanced0788-105-032026-07-27
M6898723101020Bleeding Control Kit0287-231-012026-07-22
M68920510060Sentinel Chest Trauma Kit0620-5102022-11-28
M68920510050Sentinel Chest Trauma Kit0520-5102022-08-18
M68920510030Sentinel Chest Trauma Kit0320-5102018-09-13
M6898332401060Mojo Combat Lifesaver Bag - Basic0683-324-012019-08-06
M68985205020Mojo Vehicle Rescue Bag - Advanced0285-2052026-07-22
M68985301040Mojo Vehicle Medical Bag - Basic0485-3012026-07-22
M68985303040Mojo Vehicle Medical Bag - Intermediate0485-3032026-07-22
M6898710003060Individual Trauma Kit - Advanced0687-100-032026-07-22
M6898730002040Medical Trauma Kit Shelter in Place (Intermediate)0487-300-022026-07-22
M6898730003050Medical Trauma Kit Shelter in Place (Advanced)0587-300-032026-07-22
M689HHCTUINK01030Chest Tube Insertion Kit03HHCTUINK012025-06-23
M689HHCTUINK0105030Chest Tube Insertion Kit Cast of 503HHCTUINK01-052025-06-23
M6898810502020Patrol Officer IFAK Intermediate0288-105-022018-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M689HHTWBC25010TACWrap Multi-Purpose Burn Cravat Case of 25Safeguard US Operating, LLCFPY2026-07-28
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
00743537000005BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-17
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