FDA.reportPublic FDA data

SDR-EDC1OTC

Primary DI
M689SDREDC1OTC010
Brand
SDR-EDC1OTC
Company
Safeguard US Operating, LLC
Model
01
Catalog number
SDR-EDC1OTC
Device description
Mojo Trauma kit is a tactically stocked trauma kit intended for initial responders and/or on-site personnel or individuals in emergency situations.
Published
2026-08-25
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
M689SDREDC1OTC010PrimaryHIBCC0

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
855-428-6074sales@safeguardmedical.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
M68981129060Mojo Patrol IFAK II0681-1292026-08-26
M689SDREDC1OTC050SDR-EDC1-OTC05SDR-EDC1-OTC2026-08-26
M689SDRTBBOTC060SDR Tactical Battle Belt IFAK-OTC06SDR-TBB-OTC2026-08-26
M68981139010LEO Patrol Kit0181-1392026-08-25
M68981301030MARCH IFAK Refill0381-3012026-08-25
M6898130330010MARCH IFAK RESUPPLY Cs of 300181-303-302026-08-25
M68981605020K9 Trauma Kit0281-6052026-08-25
M68987155030TX Bleeding Control Kit - Advanced0387-1552026-08-25
M68987232010Stop the Bleed Kit (NJSP)0187-2322026-08-25
M689SDRTBBOTC020SDR Tactical Battle Belt IFAK-OTC02SDR-TBBOTC2026-08-25
M689HHSCK01EA020Simplified Cricothyrotomy Kit02HHSCK01-EA2022-08-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850062467224TC3 CLS Kit, CBAltitude Technologies Inc.OHO2026-08-27
M68981129060Mojo Patrol IFAK IISafeguard US Operating, LLCOHO2026-08-26
M689SDREDC1OTC050SDR-EDC1-OTCSafeguard US Operating, LLCOHO2026-08-26
M689SDRTBBOTC060SDR Tactical Battle Belt IFAK-OTCSafeguard US Operating, LLCOHO2026-08-26
M68981139010LEO Patrol KitSafeguard US Operating, LLCOHO2026-08-25
M68981301030MARCH IFAK RefillSafeguard US Operating, LLCOHO2026-08-25
M6898130330010MARCH IFAK RESUPPLY Cs of 30Safeguard US Operating, LLCOHO2026-08-25
M68981605020K9 Trauma KitSafeguard US Operating, LLCOHO2026-08-25
M68987155030TX Bleeding Control Kit - AdvancedSafeguard US Operating, LLCOHO2026-08-25
M68987232010Stop the Bleed Kit (NJSP)Safeguard US Operating, LLCOHO2026-08-25
M689SDRTBBOTC020SDR Tactical Battle Belt IFAK-OTCSafeguard US Operating, LLCOHO2026-08-25
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