ThermaZone

Basic Information

• Brand Name: ThermaZone
• Primary DI: 00854682001172
• Version / Model: 003-04
• Catalog Number: 003-04
• Company Name: INNOVATIVE MEDICAL EQUIPMENT, LLC
• Labeler DUNS: 833969186
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2019-03-21
• Public Version Status: Update
• Public Device Record Key: 0fbe7ab7-11ac-4154-a109-9ca79f45c501

Device Description

ThermaZone Blue Tubing Assembly

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	890.5720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61228	External cuff/pad connection tubing	A length of flexible tube intended to be used to deliver air and/or fluid from a pump to a noninvasive, patient-contact pad, pack or cuff. It may be intended for use with a specific type of assembly (e.g., circulating-air/fluid thermal therapy system, electronic sphygmomanometer, venous compression system). It is typically made of synthetic material and may be intended to be permanently attached to the system control unit. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854682001172	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 60 – 85 Degrees Fahrenheit