ThermoSuit System 76003

GUDID 00851936007126

LIFE RECOVERY SYSTEMS HD LLC

Cooling utility supply system
Primary Device ID00851936007126
NIH Device Record Keye5fd1cb4-d846-4083-ac54-dac3843ce6a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameThermoSuit System
Version Model NumberActivation Kit
Catalog Number76003
Company DUNS825390458
Company NameLIFE RECOVERY SYSTEMS HD LLC
Device Count1
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 Datetrue
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
GS100851936007126 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-11
Device Publish Date2020-03-03

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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