Medi-First Large Instant Cold packP

Basic Information

• Brand Name: Medi-First Large Instant Cold packP
• Primary DI: 00347682702113
• Version / Model: 7021M
• Company Name: Medique Products
• Labeler DUNS: 086911794
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-12
• Public Version: 1
• Public Version Date: 2019-07-22
• Public Version Status: New
• Public Device Record Key: 991ff252-4206-4a54-834d-bcd68d980250

Device Description

A device intended to be applied with pressure to the body surface to provide cold therapy to help reduce fever, pain, and inflammation associated with joint/muscle/tissue injury and/or minor burns.

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: 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: Yes
• 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
60790	Endothermic cold therapy pack	A device intended to be applied with pressure to the body surface to provide cold therapy to help reduce fever, pain, and inflammation associated with joint/muscle/tissue injury and/or minor burns. It typically consists of a compact envelope made of plastic and filled with chemicals that generate an endothermic chemical reaction when activated to reduce the temperature of the pack. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50347682702118	GS1	master case	24	In Commercial Distribution
Primary	00347682702113	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature. Storage at cooler temperatures could cause frostbite after activation