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

GUDID 00849111075558

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 ID00849111075558
NIH Device Record Keyc8c48e7f-e257-4357-96a7-232259d6dd81
Commercial Distribution StatusIn Commercial Distribution
Brand NameThermogard XP, Lang set A, Non-Rohs, Refurb
Version Model NumberNA
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
GS100849111075558 [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 Date2015-07-01

Devices Manufactured by Zoll Circulation, Inc.

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00849111076104 - STX SURFACE COOLING 2024-08-23 STX SURFACE COOLING Pad L/XL PAD SET
00849111076111 - STX SURFACE COOLING2024-08-23 STX SURFACE COOLING Pad THIGHS ONLY PAD SET
00849111076074 - Thermogard HQ Surface Start-Up Kit2024-05-30 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 Kit2024-05-30 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/M2024-05-30 Thermogard™ Vest, S/M
00849111076135 - Thermogard™ Vest, L/XL2024-05-30 Thermogard™ Vest, L/XL
00849111075787 - Thermogard XP, Lang set C, Rohs2023-12-18 The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controlle

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