Thermogard XP, Lang set A, Non-Rohs, Refurb

Basic Information

• Brand Name: Thermogard XP, Lang set A, Non-Rohs, Refurb
• Primary DI: 00849111075558
• Version / Model: NA
• Company Name: Zoll Circulation, Inc.
• Labeler DUNS: 799455241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-01
• Public Version: 4
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: c8c48e7f-e257-4357-96a7-232259d6dd81

Device Description

The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• 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
NCX	System, Hypothermia, Intravenous, Cooling	Cardiovascular	870.5900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44710	Intravascular core temperature regulation system	An assembly of devices intended to regulate a patient's body temperature by circulating a temperature-controlled fluid (e.g., saline solution) through a dedicated, closed-circuit catheter placed in the central venous system (CVS), to both heat and alternatively cool the patient's blood through the transfer of heat as it moves past the catheter. It typically consists of a powered unit that controls fluid temperature and circulation, a catheter with a membrane for heat transfer, temperature probes, and a start kit. It may be used for body temperature regulation during surgery (e.g., cardiac surgery or neurosurgery), intensive care, or for fever management.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00849111075558	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K072234	000