AED Brands, LLC

Basic Information

• Brand Name: AED Brands, LLC
• Primary DI: 90865292000106
• Version / Model: AB 9131-001
• Company Name: AED BRANDS, LLC
• Labeler DUNS: 611739603
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-02-11
• Public Version: 4
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: 7de71f0a-e51c-4c27-8e7d-5582ad4d2827

Device Description

Adult electrodes for use with Cardiac Science(TM) AEDs - Can be used in place of Cardiac Science(TM) electrodes part number 9131-001

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	870.5310	3

GMDN Terms

Code	Name	Definition	Implantable	Status
11130	Electrode conductive skin pad, single-use	A noninvasive conductive material designed to facilitate electrical conduction between an external electrode (e.g., paddle-type defibrillator electrode) and the skin surface. It is available in various forms such as a thickened gel or polymer medium reinforced by a non-woven material, an adhesive pad/patch, or an absorbent material (e.g., felt) intended to be soaked in a conduction fluid. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	90865292000106	GS1
Package	90865292000113	GS1	Case	10	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K131494	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -4 – 104 Degrees Fahrenheit