EMPACT 6+ Patient Hard Case Kit with Wall Cabinet OTC

Basic Information

• Brand Name: EMPACT 6+ Patient Hard Case Kit with Wall Cabinet OTC
• Primary DI: B283E6HCXOB0
• Version / Model: B283E6HCXOB0
• Company Name: Pro1tek
• Labeler DUNS: 827067880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-27
• Public Version: 1
• Public Version Date: 2021-06-04
• Public Version Status: New
• Public Device Record Key: ad25cc4b-7b42-45fc-bad1-202bd7cd39a7

Device Description

EMPACT 6+ Patient Hard Case Kit with Wall Cabinet OTC - Tactical & Medical Kit. Tactical side has Bat Flash Light, TAC-WEGE, TAC-KEYS and other Tactical components that can be used in an active shooter RUN, HIDE, Fight situation. Medical side has bleeding control Kits featuring Hemostatic Dressing and other Trauma First- Aid equipment.

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
OVR	Kit, First Aid, Talking	General, Plastic Surgery	878.4014	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44039	First aid kit, medicated	A convenient collection of equipment, materials and pharmaceuticals intended to be used in an emergency for the rapid, initial treatment of an injury. It is typically used by emergency medical services (EMS), hospitals, institutions, schools, and other public settings. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B283E6HCXOB0	HIBCC