CozyTherm Heat Relief Wrap, Back

Basic Information

• Brand Name: CozyTherm Heat Relief Wrap, Back
• Primary DI: 00840117341050
• Version / Model: 1457
• Company Name: Dynarex Corporation
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-13
• Public Version: 1
• Public Version Date: 2025-02-21
• Public Version Status: New
• Public Device Record Key: 40b44670-fedd-40f1-9429-b0299b16c5f7

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: No
• 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
Primary	00840117341050	GS1
Package	00840117341029	GS1	Box	3	In Commercial Distribution
Package	00840117340992	GS1	Case	10	In Commercial Distribution