Thermogard HQ Surface Start-Up Kit

Primary DI
00849111076074
Brand
Thermogard HQ Surface Start-Up Kit
Company
Zoll Circulation, Inc.
Model
Surface Start-Up Kit
Catalog number
8700-000935-01
Device description
"The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surface pad. The Surface Start-Up Kit is a closed-loop disposable that is composed of a pre-attached water reservoir, an extension tubing, a pump loop, a heat exchange coil and an air trap assembly. All of these items work with the console to supply cool water to the surface pad to regulate patient core temperature."""
Published
2024-05-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NZEHyperthermia Monitor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NZEHyperthermia MonitorCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231182000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231182000Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management SystemZoll Circulation, Inc.2023-11-03NZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849111076074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849111076074008491110760748491110760740849111076074

GMDN Terms#

Term, Definition table
TermDefinition
External circulating-fluid core temperature regulation system start kitA collection of consumable devices intended to be used to facilitate the function of an external circulating-fluid core temperature regulation system. It typically includes tubing to connect the pump mechanism of the system control unit to a patient pad, a heat exchange coil, and other necessary components (e.g., water reservoir, air trap, flow indicator). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4085412140udisj@zoll.com

Regulatory Flags#

DUNS number
799455241
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration 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
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
00849111075015Thermogard XP®Thermogard XP, Lang set A, Rohs2015-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849111076296VitalTemp™ Zoll Circulation, Inc.NZE2025-12-12
10849111076293VitalTemp™ Zoll Circulation, Inc.NZE2025-12-12
00849111076081ThermoGard XP Surface Start-Up KitZoll Circulation, Inc.NZE2024-05-22
00849111076128Thermogard™ Vest, S/MZoll Circulation, Inc.NZE2024-05-22
00849111076135Thermogard™ Vest, L/XLZoll Circulation, Inc.NZE2024-05-22
00851936007126ThermoSuit SystemLIFE RECOVERY SYSTEMS HD LLCNZE2020-03-03
07640149880588TRITRI Dental Implants Int. AGNZE2019-01-30
10851936007000ThermoSuit SystemLIFE RECOVERY SYSTEMS HD LLCNZE2016-09-08
08511936007010ThermoSuit SystemLIFE RECOVERY SYSTEMS HD LLCNZE2016-09-08
10851936007079ThermoSuit SystemLIFE RECOVERY SYSTEMS HD LLCNZE2016-09-08
08511936007126ThermoSuit SystemLIFE RECOVERY SYSTEMS HD LLCNZE2016-09-08
00851936007003ThermoSuit SystemLIFE RECOVERY SYSTEMS HD LLCNZE2016-09-08
00851936007010Thermosuit SystemLIFE RECOVERY SYSTEMS HD LLCNZE2016-09-08
00851936007027ThermoSuit SystemLIFE RECOVERY SYSTEMS HD LLCNZE2016-09-08
00851936007034ThermoSuit SystemLIFE RECOVERY SYSTEMS HD LLCNZE2016-09-08
00851936007041ThermoSuit SystemLIFE RECOVERY SYSTEMS HD LLCNZE2016-09-08
00851936007058ThermoSuit SystemLIFE RECOVERY SYSTEMS HD LLCNZE2016-09-08
00851936007065ThermoSuit SystemLIFE RECOVERY SYSTEMS HD LLCNZE2016-09-08
00851936007072ThermoSuit SystemLIFE RECOVERY SYSTEMS HD LLCNZE2016-09-08
00851936007089ThermoSuit SystemLIFE RECOVERY SYSTEMS HD LLCNZE2016-09-08
00851936007096ThermoSuit SystemLIFE RECOVERY SYSTEMS HD LLCNZE2016-09-08
00851936007102ThermoSuit SystemLIFE RECOVERY SYSTEMS HD LLCNZE2016-09-08
00851936007119ThermoSuit SystemLIFE RECOVERY SYSTEMS HD LLCNZE2016-09-08