Evolution 2 0V12X1009M01

GUDID 00850033615005

Evolution, DVT, EV0001, Qty 1

THERMOTEK, INC.

Single-chamber venous compression system garment, single-use
Primary Device ID00850033615005
NIH Device Record Key03bd0189-4562-4958-8766-d28bd103c27f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEvolution 2
Version Model Number0V12X1009M01
Catalog Number0V12X1009M01
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

Phone972-874-4949
Emailslee@thermotekusa.com
Phone972-874-4949
Emailslee@thermotekusa.com
Phone972-874-4949
Emailslee@thermotekusa.com
Phone972-874-4949
Emailslee@thermotekusa.com
Phone972-874-4949
Emailslee@thermotekusa.com
Phone972-874-4949
Emailslee@thermotekusa.com
Phone972-874-4949
Emailslee@thermotekusa.com
Phone972-874-4949
Emailslee@thermotekusa.com
Phone972-874-4949
Emailslee@thermotekusa.com
Phone972-874-4949
Emailslee@thermotekusa.com
Phone972-874-4949
Emailslee@thermotekusa.com
Phone972-874-4949
Emailslee@thermotekusa.com
Phone972-874-4949
Emailslee@thermotekusa.com
Phone972-874-4949
Emailslee@thermotekusa.com
Phone972-874-4949
Emailslee@thermotekusa.com
Phone972-874-4949
Emailslee@thermotekusa.com
Phone972-874-4949
Emailslee@thermotekusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850033615005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOWSleeve, Limb, Compressible

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-30
Device Publish Date2023-08-22

Devices Manufactured by THERMOTEK, INC.

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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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