FDA.reportPublic FDA data

Cubix Safety

Primary DI
00810104540896
Brand
Cubix Safety
Company
CBX LLC
Model
FRK-NLX
Catalog number
FRK-NLX01
Device description
First responder kit containing components necessary during an opioid overdose emergency. Contains: (1) CPR barrier shield, (2) pairs large nitrile gloves, (2) NaCl wipes, (1) biohazard disposal bag, (1) dry towelette, (1) semi-rigid carry case.
Published
2025-04-18
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
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
00810104540896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810104540896008101045408968101045408960810104540896

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
110960383
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B859ERM1010Emergency Rescue MaskERM1012020-02-15
B859FRK1021First Responder KitFRK102FRK1022021-04-01
B859FRK10109First Responder KitFRK101FRK1012020-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850062467224TC3 CLS Kit, CBAltitude Technologies Inc.OHO2026-08-27
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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
M689SDREDC1OTC010SDR-EDC1OTCSafeguard 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