ThermaZone

Basic Information

• Brand Name: ThermaZone
• Primary DI: 00854682001561
• Version / Model: 003-35
• Catalog Number: 003-35
• 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: 2021-07-22
• Public Version Status: Update
• Public Device Record Key: 6ba33be5-54ad-4c30-8706-9a7280a30dd8

Device Description

ThermaZone Standard Power Supply 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: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
36545	Basic power supply, reusable	A device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854682001561	GS1

Customer Contacts

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

Storage Conditions

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