FDA.reportPublic FDA data

ThermoSuit System

Primary DI
10851936007000
Brand
ThermoSuit System
Company
LIFE RECOVERY SYSTEMS HD LLC
Model
TSP-50 Pump/Controller
Catalog number
75001
Published
2016-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NZEHyperthermia Monitor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NZEHyperthermia MonitorCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061023000THERMOSUIT SYSTEMLife Recovery Systems Hd, LLC2006-09-20NZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08511936007010Direct MarkingGS10
10851936007000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08511936007010085119360070108511936007010
1085193600700010851936007000

GMDN Terms#

Term, Definition table
TermDefinition
External circulating-fluid core temperature regulation system control unit, cooling-onlyAn electrically-powered device intended to be used as part of an external circulating-fluid core temperature regulation system to control/regulate the temperature and flow of fluid through a connected patient-applied pad (not included), to lower a patient’s core body temperature. The device includes a refrigeration unit, a pump, and typically a fluid reservoir; it may also be intended for patient temperature monitoring. It is intended to be used by a healthcare professional in a clinical setting typically to treat patients who are hyperthermic/feverish or to induce hypothermia for metabolism reduction (e.g., during surgery).

Regulatory Flags#

DUNS number
825390458
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08511936007010ThermoSuit SystemTSP-50 Pump/Controller750012016-09-08
10851936007079ThermoSuit SystemDisposable Kit, Case720042016-09-08
08511936007126ThermoSuit SystemActivation Kit760032016-09-08
00851936007003ThermoSuit SystemTSP-50 Pump/Controller590022016-09-08
00851936007010Thermosuit SystemPump Cassette Assembly710022016-09-08
00851936007027ThermoSuit SystemMulti-lumen Umbilicus Hose710032016-09-08
00851936007034ThermoSuit SystemTop Sheet710042016-09-08
00851936007041ThermoSuit SystemReservoir Liner710092016-09-08
00851936007058ThermoSuit System12F Temperature Probe720012016-09-08
00851936007065ThermoSuit SystemPatch Kit720032016-09-08
00851936007072ThermoSuit SystemDisposable Kit,Med.730012016-09-08
00851936007089ThermoSuit System18F Temperature Probe720052016-09-08
00851936007096ThermoSuit SystemTemperature Cable740062016-09-08
00851936007102ThermoSuit SystemPump/Controller Fill Hose740122016-09-08
00851936007119ThermoSuit SystemTraining Software760072016-09-08
00851936007126ThermoSuit SystemActivation Kit760032020-03-03

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
00849111076074Thermogard HQ Surface Start-Up KitZoll Circulation, Inc.NZE2024-05-22
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
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