Basic

Basic Information

• Brand Name: Basic
• Primary DI: B845ICE10560
• Version / Model: ICE1056
• Company Name: Intco Medical Industries, Inc.
• Labeler DUNS: 080162537
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-28
• Public Version: 1
• Public Version Date: 2023-05-08
• Public Version Status: New
• Public Device Record Key: 503645d6-f92d-4b60-9458-565df82a68d9

Device Description

INSTANT COLD PACK

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: Yes
• 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
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
Primary	B845ICE10560	HIBCC
Package	B845ICE10563	HIBCC		125	In Commercial Distribution