FDA.reportPublic FDA data

Thermogard XP®

Primary DI
00849111075015
Brand
Thermogard XP®
Company
Zoll Circulation, Inc.
Model
Thermogard XP, Lang set A, Rohs
Device description
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.
Published
2015-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
NCXSystem, Hypothermia, Intravenous, Cooling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NCXSystem, Hypothermia, Intravenous, CoolingCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072234000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072234000THERMOGARD XP THERMAL REGULATION SYSTEMAlsius Corp.2007-08-23NCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849111075015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849111075015008491110750158491110750150849111075015

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular heating/cooling systemAn assembly of devices intended to regulate a patient's body temperature by circulating a temperature-controlled fluid (e.g., saline solution) through a dedicated, closed-circuit catheter placed in the central venous system (CVS), to heat or cool the patient's blood through the transfer of heat as it moves past the catheter. It typically consists of a powered unit that controls fluid temperature and circulation, a catheter with a membrane for heat transfer, temperature probes, and a start-up kit. It may be used for body temperature regulation during surgery (e.g., cardiac surgery or neurosurgery), intensive care, or for fever management.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4085412140udisj@zoll.com

Regulatory Flags#

DUNS number
799455241
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849111076296VitalTemp™ VitalTemp™ Universal Pad, 2PK, US8700-0011312025-12-12
10849111076293VitalTemp™ VitalTemp™ Universal Pad, 2PK, US8700-0011312025-12-12
00849111076074Thermogard HQ Surface Start-Up KitSurface Start-Up Kit8700-000935-012024-05-22
00849111076081ThermoGard XP Surface Start-Up KitSurface Start-Up Kit8700-000936-012024-05-22
00849111076128Thermogard™ Vest, S/MS/M8700-000937-012024-05-22
00849111076135Thermogard™ Vest, L/XL L/XL8700-000938-012024-05-22
00849111076098STX SURFACE COOLING S/M PAD8700-000838-012024-08-15
00849111076104STX SURFACE COOLING L/XL PAD 8700-000839-012024-08-15
00849111076111STX SURFACE COOLINGTHIGHS ONLY PAD SET8700-000840-012024-08-15
00849111075787Thermogard XP, Lang set C, RohsThermogardHQ, Lang set C601337-0012023-01-17
00849111075794Thermogard XP, Lang set C, Rohs, RefurbThermogard XP, Lang set C, Rohs, Refurb2023-01-17
00849111075800Thermogard HQTM ConsoleThermogardHQ, Lang set A8700-001030-01 2022-06-27
00849111075862Thermogard HQTM Start-Up KitTG2-500D8700-001027-012022-06-27
00849111075879Thermogard HQTM Start-Up Kit EXTG2-500D, Extended Length8700-001028-012022-06-27
00849111050029Start-Up KitCG-500D8700-0666-032015-03-31
00849111050043ICY-3, Japan, Final Packaged Kit (Applause) IC-38938700-0657-032016-10-10
00849111050050Quattro, Japan, Final Packaged Kit (Applause) IC-45932016-10-10
00849111050074Cool Line® Intravascular Heat Exchange Catheter Kit (Applause)N/A8700-0654-032015-03-31
00849111050081Start-Up Kit JapanCG-500D8700-0785-032016-10-10
00849111075008Thermogard XP®Thermogard XP, Lang set B, Rohs2015-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849111075787Thermogard XP, Lang set C, RohsZoll Circulation, Inc.NCX2023-01-17
00849111075794Thermogard XP, Lang set C, Rohs, RefurbZoll Circulation, Inc.NCX2023-01-17
00849111075800Thermogard HQTM ConsoleZoll Circulation, Inc.NCX2022-06-27
00849111075862Thermogard HQTM Start-Up KitZoll Circulation, Inc.NCX2022-06-27
00849111075879Thermogard HQTM Start-Up Kit EXZoll Circulation, Inc.NCX2022-06-27
00849111050043ICY-3, Japan, Final Packaged Kit (Applause) Zoll Circulation, Inc.NCX2016-10-10
00849111050050Quattro, Japan, Final Packaged Kit (Applause) Zoll Circulation, Inc.NCX2016-10-10
00849111050081Start-Up Kit JapanZoll Circulation, Inc.NCX2016-10-10
00849111075176Cool Line® Intravascular Heat Exchange Catheter Kit Japan, Final Pkged Kit NeZoll Circulation, Inc.NCX2016-10-10
00849111075183Cool Line® Intravascular Heat Exchange Catheter Kit Non Heparin Custom LuerZoll Circulation, Inc.NCX2015-07-30
00849111075190Cool Line® Intravascular Heat Exchange Catheter Kit Applause Custom Luer HeparinZoll Circulation, Inc.NCX2015-07-30
00849111075213Cool Line® Intravascular Heat Exchange Catheter Kit EU Final Packaged Kit CustomZoll Circulation, Inc.NCX2015-07-30
00849111075220ICY® Intravascular Heat Exchange Catheter Kit Custom Luer Surmodics Non HeparinZoll Circulation, Inc.NCX2015-07-30
00849111075237ICY® Intravascular Heat Exchange Catheter Kit Custom Luer Applause (Heparin)Zoll Circulation, Inc.NCX2015-07-30
00849111075251ICY® Intravascular Heat Exchange Catheter Kit EU Applause Custom Luer (Heparin)Zoll Circulation, Inc.NCX2015-07-30
00849111075268QUATTRO® Intravascular Heat Exchange Catheter Kit Custom Luer Surmodics Non-HepZoll Circulation, Inc.NCX2015-07-30
00849111075275QUATTRO® Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin EZoll Circulation, Inc.NCX2015-07-30
00849111075282QUATTRO® Intravascular Heat Exchange Catheter Kit Custom Luer Applause (Heparin)Zoll Circulation, Inc.NCX2015-07-30
00849111075305SOLEX® Intravascular Heat Exchange Catheter Primum Kit Custom Luer Applause HepZoll Circulation, Inc.NCX2015-07-30
00849111075312SOLEX® Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin EUZoll Circulation, Inc.NCX2015-07-30
00849111075503Quattro, Heparin, Premium Kit, USZoll Circulation, Inc.NCX2015-07-30
00849111075336Start-Up Kit Custom LuerZoll Circulation, Inc.NCX2015-07-15
00849111075350Start-Up Kit Extended Length, Custom LuerZoll Circulation, Inc.NCX2015-07-15
00849111075381InnerCool RTx 10.7F Standard CatheterZoll Circulation, Inc.NCX2015-07-01
00849111075398InnerCool RTx 14F Standard CatheterZoll Circulation, Inc.NCX2015-07-01
0084911107540410.7F PACKAGED ACCUTROL CATHETERZoll Circulation, Inc.NCX2015-07-01
0084911107541114F PACKAGED ACCUTROL CATHETERZoll Circulation, Inc.NCX2015-07-01
00849111075428CATHETER INTRODUCER KIT, 14FZoll Circulation, Inc.NCX2015-07-01
00849111075435CATHETER INTRODUCER KIT, 10.7FZoll Circulation, Inc.NCX2015-07-01
00849111075442RTX CIRCULATING CASSETTE WITH ELECTROLYTEZoll Circulation, Inc.NCX2015-07-01