ThermoChem

Basic Information

• Brand Name: ThermoChem
• Primary DI: 00851450007008
• Version / Model: HT-2000
• Catalog Number: HT-2000
• Company Name: THERMASOLUTIONS, INC.
• Labeler DUNS: 186855925
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: ed626c6a-c101-4fca-ad79-d1daefb82113

Device Description

The ThermoChem HT is a hyperthermia device that continuously circulates a heated sterile solution throughout the patients abdomen. The device accurately raises temperature to a predetermined target selected by the physician.

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: No
• 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
MLW	Warmer, Peritoneal Dialysate	Gastroenterology, Urology	876.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37921	Intracavitary-circulation hyperthermia system	An assembly of electrically-powered devices designed to continuously lavage body cavities (e.g., pleural cavity, peritoneal cavity, bladder lumen) with warmed fluids/chemotherapeutic agents to raise the local temperature and/or enhance the effect of drugs, typically in the treatment of malignancy. It typically includes a water heater/cooler, fluid pump, controls, inputs for monitoring temperature, a circuit with heat exchanger, fluid reservoir, and tubing connectors. Introduction/drainage catheters are connected to the system and placed in the body cavity.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851450007008	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Depth	43	Centimeter
Width	44	Centimeter
Weight	102	Kilogram
Height	131	Centimeter