LEADER

Basic Information

• Brand Name: LEADER
• Primary DI: 00096295131239
• Version / Model: 5312095
• Catalog Number: 5312095
• Company Name: Cardinal Health 110, Inc.
• Labeler DUNS: 063997360
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2019-07-17
• Public Version: 3
• Public Version Date: 2022-05-10
• Public Version Status: Update
• Public Device Record Key: bd1e31d2-4fd1-4034-bd3c-032509fe4e08

Device Description

Heatwraps Small 8 hour 3 ea

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: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
OMW	Adhesive backed thermal skin patches	Physical Medicine	890.5710	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37697	Exothermic heat therapy pack/patch	A device intended to be applied to the body surface, sometimes with pressure, to provide heat therapy to reduce muscle spasms and cramps and/or for joint and muscle stiffness and pain. It includes an envelope(s) filled with a material that produces an exothermic chemical reaction when activated; it may be available in a variety of forms (e.g., adhesive patch, belt containing packs). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30096295131230	GS1	PACK	6	In Commercial Distribution
Primary	00096295131239	GS1
Package	50096295131234	GS1	CASE	4	In Commercial Distribution
Unit of Use	10096295131236	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	11.4	Inch
Width	3.7	Inch