ThermoSuit System 72004

GUDID 10851936007079

LIFE RECOVERY SYSTEMS HD LLC

External circulating-fluid core temperature regulation system control unit, cooling-only
Primary Device ID10851936007079
NIH Device Record Keyabf819a8-68d8-4d21-9133-246e9bda34a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameThermoSuit System
Version Model NumberDisposable Kit, Case
Catalog Number72004
Company DUNS825390458
Company NameLIFE RECOVERY SYSTEMS HD LLC
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851936007100 [Unit of Use]
GS110851936007079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NZEHyperthermia Monitor

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-12-18
Device Publish Date2016-09-08

On-Brand Devices [ThermoSuit System]

00851936007119Training Software
00851936007102Pump/Controller Fill Hose
00851936007096Temperature Cable
0085193600708918F Temperature Probe
00851936007072Disposable Kit,Med.
00851936007065Patch Kit
0085193600705812F Temperature Probe
00851936007041Reservoir Liner
00851936007034Top Sheet
00851936007027Multi-lumen Umbilicus Hose
00851936007010Pump Cassette Assembly
00851936007003TSP-50 Pump/Controller
00851936007126Activation Kit
08511936007126Activation Kit
10851936007079Disposable Kit, Case
08511936007010TSP-50 Pump/Controller

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