LEADER

Basic Information

• Brand Name: LEADER
• Primary DI: 00096295125559
• Version / Model: 4935516
• Catalog Number: 4935516
• Company Name: Cardinal Health 110, Inc.
• Labeler DUNS: 063997360
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-18
• Public Version: 2
• Public Version Date: 2021-07-02
• Public Version Status: Update
• Public Device Record Key: 1e1937e7-055e-42b5-aac4-34345b91167b

Device Description

First Aid Kit; First Aid Essentials; Pack and Go Convenience; 12 Items and 1 Carrying Case; 6 Fabric Antibacterial Bandages with First Aid Antiseptic; Active Ingredient: Benzalkonium Chloride 0.1 percent; 2 Hand Cleansing Wipes; 4 Sterile Pads; For External Use Only

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• 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
Package	50096295125554	GS1	CASE	48	In Commercial Distribution
Primary	00096295125559	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]