ARTEK PRO-01 0P9PTATP01UNVWRC01

GUDID 00850033615067

ARTEK PRO-01 W/UNV WRAP, COMP01

THERMOTEK, INC.

Circulating-fluid thermal therapy system pack, single-use
Primary Device ID00850033615067
NIH Device Record Key502c6adc-8509-4de8-98bd-639deb8f7b44
Commercial Distribution StatusIn Commercial Distribution
Brand NameARTEK PRO-01
Version Model Number0P9PTATP01UNVWRC01
Catalog Number0P9PTATP01UNVWRC01
Company DUNS847899911
Company NameTHERMOTEK, INC.
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com
Phone9728744949
Emailslee@thermotekusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850033615067 [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.

00850033615005 - Evolution 22023-08-30 Evolution, DVT, EV0001, Qty 1
00850033615012 - ARTEK SPORT-01 w UNIV-01, Qty 12023-03-09 ARTEK SPORT-01 w 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 2023-03-09ARTEK PRO-01 W/UNV WRAP, COMP01
00850033615067 - ARTEK PRO-01 2023-03-09 ARTEK PRO-01 W/UNV WRAP, COMP01
B5850P9PT09SYS0 - PT92019-03-12 PT9 Therapy System
B5850P9PTVT4000 - VascuTherm42019-03-12 VascuTherm4 Therapy System
B5850P9PTVT5000 - VascuTherm52019-03-12 VascuTherm5 Therapy System

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