ThermoSuit System 76003

GUDID 08511936007126

LIFE RECOVERY SYSTEMS HD LLC

Circulating-fluid whole-body cooling system control unit
Primary Device ID08511936007126
NIH Device Record Key6a5604f1-db6e-44a2-abea-bbf1354f683b
Commercial Distribution Discontinuation2021-03-05
Commercial Distribution StatusNot in 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108511936007126 [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 Date2021-03-08
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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