Moist Hot-Pack Unit

Basic Information

• Brand Name: Moist Hot-Pack Unit
• Primary DI: 08809520550499
• Version / Model: KRS-8P-A2D32
• Company Name: KARIS Co.,Ltd
• Labeler DUNS: 689514726
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-23
• Public Version: 1
• Public Version Date: 2023-03-03
• Public Version Status: New
• Public Device Record Key: 2f8114c3-623a-47e6-9578-5f4ba77ecadd

Device Description

It is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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
IRQ	Unit, Heating, Powered	Physical Medicine	890.5950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38469	Hot therapy pack heating unit	A mains electricity (AC-powered) device used to heat the contents of a reusable hot therapy pack to temperatures appropriate to apply heat therapy to the human body. This device, also known as a hydrocollator, typically consists of a stainless steel container, shelves, trays, or drawers that facilitate the heating and handling of the many hot therapy packs, and heating elements that heat the packs to a specified temperature so that the they are conditioned for reuse when needed. It is typically used in accident and emergency (A&E) rooms, rehabilitation facilities and for physiotherapy treatments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809520550499	GS1

Customer Contacts

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