Thermogard XP, Lang set C, Rohs, Refurb

GUDID 00849111075794

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.

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• Primary Device ID: 00849111075794
• NIH Device Record Key: 466f7225-dde0-4dcf-8629-5b9e3caffac4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermogard XP, Lang set C, Rohs, Refurb
• Version Model Number: Thermogard XP, Lang set C, Rohs, Refurb
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849111075794 [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: 2
• Public Version Date: 2023-12-18
• Device Publish Date: 2023-01-17

Devices Manufactured by Zoll Circulation, Inc.

• 00849111076074 - Thermogard HQ Surface Start-Up Kit: 2024-05-30 The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surfac
• 00849111076081 - ThermoGard XP Surface Start-Up Kit: 2024-05-30 The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surfac
• 00849111076128 - Thermogard™ Vest, S/M: 2024-05-30 Thermogard™ Vest, S/M
• 00849111076135 - Thermogard™ Vest, L/XL: 2024-05-30 Thermogard™ Vest, L/XL
• 00849111075787 - Thermogard XP, Lang set C, Rohs: 2023-12-18 The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controlle
• 00849111075794 - Thermogard XP, Lang set C, Rohs, Refurb: 2023-12-18The 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.
• 00849111075794 - Thermogard XP, Lang set C, Rohs, Refurb: 2023-12-18 The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controlle
• 00849111002998 - AutoPulse Li-ion Battery: 2023-10-25 Box containing a Lithium Ion (Li-Ion) battery for use with the AutoPulse ® Platform System.
• 00849111003032 - AutoPulse NXT: 2023-10-25 AutoPulse NXT Quick Case.