FDA.reportPublic FDA data

ThermoSuit System

Primary DI
08511936007010
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
OTC
false
Sterile
false
Single use
false

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
825390458
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10851936007000ThermoSuit 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
10851936007000ThermoSuit 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