Thermogard XP®

GUDID 00849111075008

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

• Primary Device ID: 00849111075008
• NIH Device Record Key: 387a0917-6276-4542-816f-fd5cc3526cb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermogard XP®
• Version Model Number: Thermogard XP, Lang set B, 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	00849111075008 [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