ThermoChem

Basic Information

• Brand Name: ThermoChem
• Primary DI: 00851450007015
• Version / Model: IPH Procedure Kit
• Catalog Number: 111-2000
• 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: 1ec0d045-0701-49f6-b4ad-67da33987b9d

Device Description

The IPH Procedure kit contains the sterile components needed to perform a hyperthermic lavage. The disposable items are intended for single use. The kit contains sterile tubing, inflow and outflow cannulae, temperature monitoring probes, heat exchanger and reservoir.

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
56634	Intraperitoneal-circulation hypothermia system administration kit	A collection of sterile devices designed to be used in the function of an automated peritoneal lavage system (APLS). It typically includes tubing to connect the infusion/extraction pump mechanism of the control unit and the other components of the system [also known as the lavage administration set (LAS)], a peritoneal lavage catheter, a heat exchanger, a core body temperature probe (e.g., oesophageal), an infusate temperature sensor, a peritoneal pressure sensor, waste receptacle, and other appropriate devices for this treatment. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851450007015	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Depth	8	Inch
Width	15	Inch
Length	30	Inch
Weight	11	Pound