LEADER

Basic Information

• Brand Name: LEADER
• Primary DI: 00096295122206
• Version / Model: 4556809
• Catalog Number: 4556809
• Company Name: Cardinal Health 110, Inc.
• Labeler DUNS: 063997360
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-27
• Public Version: 4
• Public Version Date: 2021-07-02
• Public Version Status: Update
• Public Device Record Key: a9e3420d-c8b9-499f-abbb-af5f4ddc77a4

Device Description

LDR Heating Pad Moist / Dry King Size Electric 60-minute auto-off

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Serial Number: No
• 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
IRT	PAD, HEATING, POWERED	Physical Medicine	890.5740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62194	Electric pad localized-body heating system	An assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is intended for use in the home or a clinical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50096295122201	GS1	CASE	6	In Commercial Distribution
Primary	00096295122206	GS1

Customer Contacts

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