ArTek Sport Wrap 0V9BSPRTUNVWRP01

GUDID 00850033615036

Wrap, ArTek Sport,Univ-01,Qty 1

THERMOTEK, INC.

Circulating-fluid thermal/compression therapy system wrap
Primary Device ID00850033615036
NIH Device Record Key19378af4-80e4-45f1-8f06-9fa7e4800fe0
Commercial Distribution StatusIn Commercial Distribution
Brand NameArTek Sport Wrap
Version Model Number0V9BSPRTUNVWRP01
Catalog Number0V9BSPRTUNVWRP01
Company DUNS847899911
Company NameTHERMOTEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 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
GS100850033615036 [Primary]

FDA Product Code

ILOPack, Hot Or Cold, Water Circulating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-09
Device Publish Date2023-03-01

Devices Manufactured by THERMOTEK, INC.

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00850033615012 - ARTEK SPORT-01 w UNIV-01, Qty 12023-03-09 ARTEK SPORT-01 w UNIV-01, Qty 1
00850033615036 - ArTek Sport Wrap2023-03-09Wrap, ArTek Sport,Univ-01,Qty 1
00850033615036 - ArTek Sport Wrap2023-03-09 Wrap, ArTek Sport,Univ-01,Qty 1
00850033615050 - ARTEK PRO-01 WRAP2023-03-09 WRAP, ARTEK PRO-01, UNV COMP01
00850033615067 - ARTEK PRO-01 2023-03-09 ARTEK PRO-01 W/UNV WRAP, COMP01
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B5850P9PTVT4000 - VascuTherm42019-03-12 VascuTherm4 Therapy System
B5850P9PTVT5000 - VascuTherm52019-03-12 VascuTherm5 Therapy System

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