FDA.reportPublic FDA data

TRAMEDIC® TRAUMA BANDAGE

Primary DI
00818630011705
Brand
TRAMEDIC® TRAUMA BANDAGE
Company
TACTICAL MEDICAL SOLUTIONS, LLC
Model
A
Catalog number
TR011
Device description
The Tramedic® Trauma Bandage is a simple, effective pressure dressing designed to treat non-life threatening hemorrhaging. It utilizes an elastic wrap material that can be used to generate pressure and a sterile wound pad that can be placed directly over the injury to aid the control of bleeding. The bandage is flat folded and vacuum-sealed to create a low profile so it can be easily stored.
Published
2020-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MHWDressing, Compression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHWDressing, CompressionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818630011705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818630011705008186300117058186300117050818630011705

GMDN Terms#

Term, Definition table
TermDefinition
First aid gauze/bandageA wound cover intended to be used as an initial, short-term treatment after injury. It typically consists of a gauze pad (e.g., cotton wool or lint) that is attached to a roll bandage (e.g., cotton or cotton/viscose). The pad is applied directly to the wound, and the bandage is subsequently wrapped around the pad and secured. The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding, and introduce medications placed on the pad. This is a single-use device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Radiation Sterilization""]"
Ethylene Oxide;Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
864-224-0081info@tacmedsolutions.com

Regulatory Flags#

DUNS number
131480662
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818630019053BRIDGE™ FRIDGE RefrigeratorA1041262026-05-05
00818630019008Expeditionary Refrigerator (xFRIDGE™)A1039872026-04-24
00860015036803Expeditionary RefrigeratorA2026-01-07
00199284492608TacMed™ Vascular Access KitAVAK2025-04-29
00818630016328Tension Pneumothorax Kit w/ CapnospotA2025-03-31
00818630010456HELIOS SystemAHELIOS-K2025-03-26
00818630010463HELIOS SystemAHELIOS-KW2025-03-26
00818630010524Foxtrot Litter with ACU CarrierAF-LITC-A2020-10-21
00818630010531Foxtrot Litter with Black CarrierAF-LITC-B2020-10-21
00818630010555Foxtrot Litter with Tan CarrierAF-LITC-T2020-10-21
00818630010562Foxtrot Litter DA, with ACU CarrierAF-LITC-DA-A2020-10-21
00818630010579Foxtrot Litter DA, with Black CarrierAF-LITC-DA-B2020-10-21
00818630010586Foxtrot Litter DA, with Tan CarrierAF-LITC-DA-T2020-10-21
00818630014027Foxtrot Litter DA, with Orange CarrierAF-LITC-DA-RO2020-10-21
00818630014508Foxtrot Litter with Orange CarrierAF-LITC-RO2020-10-21
00818630014515Foxtrot Litter with Red CarrierAF-LITC-R2020-10-21
00818630014522Foxtrot Litter DA, with Red CarrierAF-LITC-DA-R2020-10-21
00818630014539Foxtrot Litter DA, with Green CarrierAF-LITC-DA-OD2020-10-21
00818630014546Foxtrot Litter, No CarrierAF-LIT2020-10-21
00818630014553Foxtrot Litter DA, no CarrierAF-LIT-DA2020-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M68932700080BATTLE BANDAGESafeguard US Operating, LLCMHW2025-08-01
10884450828752SAFEGUARD FOCUS COOL™Merit Medical Systems, Inc.MHW2025-07-01
10884450844240SAFEGUARD FOCUS COOL™Merit Medical Systems, Inc.MHW2025-03-07
M68931150030TQ™ RAMSafeguard US Operating, LLCMHW2025-01-29
10884450828745SAFEGUARD FOCUS™Merit Medical Systems, Inc.MHW2025-01-01
10193489084658MEDLINEMEDLINE INDUSTRIES, INC.MHW2024-09-13
00810041983572ViveVIVE HEALTH LLCMHW2024-06-07
00810041983589ViveVIVE HEALTH LLCMHW2024-06-07
00810041983596ViveVIVE HEALTH LLCMHW2024-06-07
00810041983602ViveVIVE HEALTH LLCMHW2024-06-07
00810041983619ViveVIVE HEALTH LLCMHW2024-06-07
00810041982087ViveVIVE HEALTH LLCMHW2024-06-05
00840117327825"Sensi Wrap,Self-Adherent - Latex Free 2 x 5"" yds Green"Dynarex CorporationMHW2023-12-20
00840117327849"Sensi Wrap,Self-Adherent - Latex Free 2 x 5"" yds Light Blue"Dynarex CorporationMHW2023-12-20
00840117327863"Sensi Wrap,Self-Adherent - Latex Free 2"" x 5 yds Purple "Dynarex CorporationMHW2023-12-20
00840117327887"Sensi Wrap,Self-Adherent - Latex Free 2"" x 5 yd Pink"Dynarex CorporationMHW2023-12-20
00840117327900"Sensi Wrap,Self-Adherent - Latex Free 3"" x 5 yds Red"Dynarex CorporationMHW2023-12-20
00840117327924"Sensi Wrap,Self-Adherent - Latex Free 3"" x 5 yds Green"Dynarex CorporationMHW2023-12-20
00840117327726"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Green"Dynarex CorporationMHW2023-12-17
00840117327740"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Blue"Dynarex CorporationMHW2023-12-17
00840117327764"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Purple "Dynarex CorporationMHW2023-12-17
00840117327788"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Pink"Dynarex CorporationMHW2023-12-17
00840117327801"Sensi Wrap,Self-Adherent - Latex Free 2"" x 5 yd Red "Dynarex CorporationMHW2023-12-17
10811331010173Comfort BandTz Medical, Inc.MHW2023-10-20
10811331010180Comfort BandTz Medical, Inc.MHW2023-10-20
00810113571249ViveVIVE HEALTH LLCMHW2023-08-07
00810113571256ViveVIVE HEALTH LLCMHW2023-08-07
00810113571959ViveVIVE HEALTH LLCMHW2023-08-07
00810113571966ViveVIVE HEALTH LLCMHW2023-08-07
00810113571973ViveVIVE HEALTH LLCMHW2023-08-07