HurriChem Device Kit

GUDID 00851450007299

HurriChem Device Kit is indicated for use in patients undergoing a laparoscopic procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to lavage blood and tissue debris from the surgical site.

THERMASOLUTIONS, INC.

Atomizing surgical topical solution applicator

• Primary Device ID: 00851450007299
• NIH Device Record Key: 4ad62638-be42-4a3a-b932-45bcabbbaf70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HurriChem Device Kit
• Version Model Number: PDT-5800
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Height: 4 Centimeter
• Width: 35 Centimeter
• Depth: 15 Centimeter
• Height: 4 Centimeter
• Width: 35 Centimeter
• Depth: 15 Centimeter
• Height: 4 Centimeter
• Width: 35 Centimeter
• Depth: 15 Centimeter
• Height: 4 Centimeter
• Width: 35 Centimeter
• Depth: 15 Centimeter
• Height: 4 Centimeter
• Width: 35 Centimeter
• Depth: 15 Centimeter
• Height: 4 Centimeter
• Width: 35 Centimeter
• Depth: 15 Centimeter
• Height: 4 Centimeter
• Width: 35 Centimeter
• Depth: 15 Centimeter
• Height: 4 Centimeter
• Width: 35 Centimeter
• Depth: 15 Centimeter
• Height: 4 Centimeter
• Width: 35 Centimeter
• Depth: 15 Centimeter
• Height: 4 Centimeter
• Width: 35 Centimeter
• Depth: 15 Centimeter
• Height: 4 Centimeter
• Width: 35 Centimeter
• Depth: 15 Centimeter
• Height: 4 Centimeter
• Width: 35 Centimeter
• Depth: 15 Centimeter
• Height: 4 Centimeter
• Width: 35 Centimeter
• Depth: 15 Centimeter
• Height: 4 Centimeter
• Width: 35 Centimeter
• Depth: 15 Centimeter
• Height: 4 Centimeter
• Width: 35 Centimeter
• Depth: 15 Centimeter
• Height: 4 Centimeter
• Width: 35 Centimeter
• Depth: 15 Centimeter
• Height: 4 Centimeter
• Width: 35 Centimeter
• Depth: 15 Centimeter
• Height: 4 Centimeter
• Width: 35 Centimeter
• Depth: 15 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851450007299 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222575

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-18
• Device Publish Date: 2023-05-10

Devices Manufactured by THERMASOLUTIONS, INC.

• 00851450007237 - ThermaSolutions: 2023-06-19
• 00851450007244 - ThermaSolutions: 2023-06-19
• 00851450007268 - ThermaSolutions: 2023-06-19
• 00851450007305 - ThermaSolutions: 2023-06-19
• 00851450007299 - HurriChem Device Kit: 2023-05-18HurriChem Device Kit is indicated for use in patients undergoing a laparoscopic procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to lavage blood and tissue debris from the surgical site.
• 00851450007299 - HurriChem Device Kit: 2023-05-18 HurriChem Device Kit is indicated for use in patients undergoing a laparoscopic procedure. It is designed to deliver sterile irr
• 00851450007282 - ThermoChem: 2022-06-15 The IPH Procedure kit contains the sterile components needed to perform a hyperthermic lavage. The disposable items are intende
• 00851450007275 - ThermoChem: 2022-06-14 The IPH Procedure kit contains the sterile components needed to perform a hyperthermic lavage. The disposable items are intende
• 00851450007114 - ThermaSolutions: 2021-05-14 Temperature probe-single TMP-1304