Thermogard XP®

GUDID 00849111075015

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 ID00849111075015
NIH Device Record Key2f038c80-b3ca-415c-b936-0095c6341dee
Commercial Distribution StatusIn Commercial Distribution
Brand NameThermogard XP®
Version Model NumberThermogard XP, Lang set A, Rohs
Company DUNS799455241
Company NameZoll Circulation, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100849111075015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NCXSystem, Hypothermia, Intravenous, Cooling

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-03-31

On-Brand Devices [Thermogard XP®]

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

Trademark Results [Thermogard XP]

Mark Image

Registration | Serial
Company
Trademark
Application Date
THERMOGARD XP
THERMOGARD XP
77088799 3528160 Live/Registered
ZOLL CIRCULATION, INC.
2007-01-23

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