Cold Care Pack

Basic Information

• Brand Name: Cold Care Pack
• Primary DI: 00815212022883
• Version / Model: CP1002
• Company Name: Izi Medical Products, LLC
• Labeler DUNS: 933506164
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-08
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: c61e35f2-3b30-4a9b-9d3a-cb3a1e2b73bc

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
IME	Pack, Hot Or Cold, Reuseable	Physical Medicine	890.5700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36034	Cold therapy pack chilling unit	A mains electricity (AC-powered) device used to chill the contents of a reusable cold therapy pack or hot/cold therapy pack to temperatures appropriate to apply cold 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 chilling and handling of the many cold therapy packs, and chilling elements (e.g., integral coils) that create temperatures of around minus 17? Celsius. 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	00815212022883	GS1