FDA.reportPublic FDA data

Easy Carry Trauma Kit

Primary DI
M689HHECTK010
Brand
Easy Carry Trauma Kit
Company
Safeguard US Operating, LLC
Model
1
Catalog number
HHECTK-01
Device description
"SWAT-TORG SWAT-T Tourniquet, Orange30-212 MARCH Celox Rapid B-CON 3""x2' OTCHVS01 H*VENT Vented Chest Seal, SingleHHMCB01 Mini-Compression Bandage (Sterile) - 4"" x 6"" abdominal padGLOVES-2.00.101 Synmax, Blue, Industrial Grade, Powered Free, Latex FreeL01-002 2X4WHITE BLANK LABELP88-100 Pouch, 6X12-LE Kit "
Published
2022-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
M689HHECTK010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pressure bandage, non-latex, single-useA strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118492643
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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M6898010020040INTRAVENOUS INFUSION STARTER SET Case of 200480-100-202026-05-04
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M68980801R120Fresh Whole Blood Recipient Set1280-801-R2026-05-04
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M689801101006080-110-10 Saline Lock Kit Case of 100680-110-102026-05-29
M68980110150SALINE LOCK KIT1580-1102026-05-29
M6898143003020Maritime Boat Box - Advanced0281-430-032026-05-28
M6898444601190Mojo Multi Mission - Advanced1984-446-012026-05-27
M689HHCTUINK01050Chest Tube Insertion Kit05HHCTUINK012026-05-27
M689HHCTUINK0105050Chest Tube Insertion Kit Cast of 505HHCTUINK01-052026-05-27
M689801101005080-110-10 Saline Lock Kit Case of 100580-110-102025-04-16
M68980110140SALINE LOCK KIT1480-1102025-01-11
M6898143003010Maritime Boat Box - Advanced0181-430-032025-07-11
M689HHCTUINK01040Chest Tube Insertion Kit04HHCTUINK012025-12-19

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