FDA.reportPublic FDA data

SCHOOL TRAUMA ADVANCED RESPONSE KIT

Primary DI
M689SHSTARTPAXSM030
Brand
SCHOOL TRAUMA ADVANCED RESPONSE KIT
Company
Safeguard US Operating, LLC
Model
03
Catalog number
SH-START-PAX-SM
Device description
This kit is intended to be carried and used by dedicated non-medical First Responders designed for treatment of Massive Hemorrhage.
Published
2026-06-22
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
OHOFirst Aid Kit Without Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHOFirst Aid Kit Without DrugGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M689SHSTARTPAXSM030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
First aid kit, non-medicated, single-useA convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
855-428-6074fulfillment@combatmedical.com

Regulatory Flags#

DUNS number
118492643
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
M68985201020Mojo Vehicle Rescue Bag - Basic0285-2012026-01-30
M6898723101030Bleeding Control Kit0387-231-012026-07-30
M689HHTWBC020TACWrap Multi-Purpose Burn Cravat02HHTWBC2026-07-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842209139620NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139637NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139644NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139651NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139668NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139675NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139705NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139750NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139811NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139828NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139835NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139842NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00199972000443CuraplexBOUND TREE MEDICAL, LLCOHO2026-08-15
00199972000450CuraplexBOUND TREE MEDICAL, LLCOHO2026-08-15
00850056748742Pacific BiomedicalINTEGRATED MEDCRAFT LLCOHO2026-07-31
00850056748735Pacific BiomedicalINTEGRATED MEDCRAFT LLCOHO2026-07-30
M6898723101030Bleeding Control KitSafeguard US Operating, LLCOHO2026-07-30
M6898810501060Patrol Officer IFAK BasicSafeguard US Operating, LLCOHO2026-07-27
M6898810502060Patrol Officer IFAK IntermediateSafeguard US Operating, LLCOHO2026-07-27
M6898810503070Patrol Officer IFAK AdvancedSafeguard US Operating, LLCOHO2026-07-27
00850070635202TRAUMA RESPONSE KITNar Medical Depot, LLCOHO2026-07-24
M68985205020Mojo Vehicle Rescue Bag - AdvancedSafeguard US Operating, LLCOHO2026-07-22
M68985301040Mojo Vehicle Medical Bag - BasicSafeguard US Operating, LLCOHO2026-07-22
M68985303040Mojo Vehicle Medical Bag - IntermediateSafeguard US Operating, LLCOHO2026-07-22
M6898710003060Individual Trauma Kit - AdvancedSafeguard US Operating, LLCOHO2026-07-22
M6898723101020Bleeding Control KitSafeguard US Operating, LLCOHO2026-07-22
M6898730002040Medical Trauma Kit Shelter in Place (Intermediate)Safeguard US Operating, LLCOHO2026-07-22
M6898730003050Medical Trauma Kit Shelter in Place (Advanced)Safeguard US Operating, LLCOHO2026-07-22
00199972000504CuraplexBOUND TREE MEDICAL, LLCOHO2026-07-17
00842209139255NAR KitNORTH AMERICAN RESCUE, LLCOHO2026-07-06