ThermoChem 111-2000

GUDID 00851450007015

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.

THERMASOLUTIONS, INC.

Intraperitoneal-circulation hypothermia system administration kit

• Primary Device ID: 00851450007015
• NIH Device Record Key: 1ec0d045-0701-49f6-b4ad-67da33987b9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermoChem
• Version Model Number: IPH Procedure Kit
• Catalog Number: 111-2000
• Company DUNS: 186855925
• Company Name: THERMASOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 651 209-3900
• Email: info@thermasolutions.com

Device Dimensions

• Weight: 11 Pound
• Weight: 11 Pound
• Weight: 11 Pound
• Weight: 11 Pound

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851450007015 [Primary]

FDA Product Code

• MLW: Warmer, Peritoneal Dialysate

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-16

On-Brand Devices [ThermoChem]

• 00851450007091: replacement sterile table pack in the event the sterility of the IPH table pack has been comprom
• 00851450007053: The ThermoChem HT is a hyperthermia device that continuously circulates a heated sterile solutio
• 00851450007015: The IPH Procedure kit contains the sterile components needed to perform a hyperthermic lavage.
• 00851450007008: The ThermoChem HT is a hyperthermia device that continuously circulates a heated sterile solutio
• 00851450007275: The IPH Procedure kit contains the sterile components needed to perform a hyperthermic lavage.
• 00851450007282: The IPH Procedure kit contains the sterile components needed to perform a hyperthermic lavage.