Cubix Safety

Basic Information

• Brand Name: Cubix Safety
• Primary DI: 00810104540896
• Version / Model: FRK-NLX
• Catalog Number: FRK-NLX01
• Company Name: CBX LLC
• Labeler DUNS: 110960383
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-18
• Public Version: 1
• Public Version Date: 2025-04-28
• Public Version Status: New
• Public Device Record Key: 9589d813-5d8d-4db4-9e4a-d2d0f3fd9d8c

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OHO	First Aid Kit Without Drug	General, Plastic Surgery	878.4014	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44047	First aid kit, non-medicated, single-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810104540896	GS1