DEFIB Pads

Basic Information

• Brand Name: DEFIB Pads
• Primary DI: 00813150020008
• Version / Model: D326
• Catalog Number: D326
• Company Name: GRAPHIC CONTROLS ACQUISITION CORP
• Labeler DUNS: 002111896
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-04-29
• Public Version: 7
• Public Version Date: 2023-03-03
• Public Version Status: Update
• Public Device Record Key: 2f0bd61a-3c98-46a0-9693-6738765d0b08
• Distribution End Date: 2023-03-02

Device Description

Cardiac Science Adult AED Pad

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: No
• 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	00813150020008	GS1
Package	10813150020005	GS1	BOX	10	Not in Commercial Distribution	2023-03-02

Customer Contacts

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