MEDZAH INSTANT HOT PACK

Basic Information

• Brand Name: MEDZAH INSTANT HOT PACK
• Primary DI: 10860011917486
• Version / Model: SAM-2000
• Company Name: Medzah Industries
• Labeler DUNS: 114193536
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-30
• Public Version: 2
• Public Version Date: 2026-01-12
• Public Version Status: Update
• Public Device Record Key: 97b3d864-519d-466e-999a-cabe81435a2b

Device Description

Instant Hot Pack 6x6 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: Yes
• 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
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	890.5710	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40555	Musculoskeletal hot/cold therapy pack, single-use	A non-powered device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck, nor is it designed to be dedicated to eye thermal therapy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20860011917483	GS1		24	In Commercial Distribution
Primary	10860011917486	GS1

Customer Contacts

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