MEDZAH INFANT HEEL WARMER

Basic Information

• Brand Name: MEDZAH INFANT HEEL WARMER
• Primary DI: 10860011917493
• Version / Model: SAM-108
• Company Name: Medzah Industries
• Labeler DUNS: 114193536
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2025-07-30
• Public Version: 1
• Public Version Date: 2025-08-07
• Public Version Status: New
• Public Device Record Key: e858f6f8-b623-40cb-b190-ca8872906ddc

Device Description

Infant Heel Warmer 5.5x3.75 inch

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
MPO	Infant Heel Warmer (Chemical Heat Pack)	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	20860011917490	GS1		4	In Commercial Distribution
Primary	10860011917493	GS1
Unit of Use	00860011917496	GS1

Customer Contacts

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