Thermogard XP®

GUDID 00849111075022

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.

Zoll Circulation, Inc.

Intravascular heating/cooling system Intravascular core temperature regulation system Intravascular core temperature regulation system Intravascular core temperature regulation system Intravascular core temperature regulation system Intravascular core temperature regulation system Intravascular core temperature regulation system Intravascular core temperature regulation system Intravascular core temperature regulation system Intravascular core temperature regulation system Intravascular core temperature regulation system Intravascular core temperature regulation system Intravascular core temperature regulation system Intravascular core temperature regulation system Intravascular core temperature regulation system Intravascular core temperature regulation system Intravascular core temperature regulation system

• Primary Device ID: 00849111075022
• NIH Device Record Key: 224024fb-8fef-4a0b-967b-033769362031
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermogard XP®
• Version Model Number: Thermogard XP, Lang set A, Non-Rohs
• Company DUNS: 799455241
• Company Name: Zoll Circulation, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849111075022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072234

FDA Product Code

• NCX: System, Hypothermia, Intravenous, Cooling

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-03-31

On-Brand Devices [Thermogard XP®]

• 00849111075022: The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature
• 00849111075015: The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature
• 00849111075008: The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature