Evolution 2 0V12X1009M01

GUDID 00850033615005

Evolution, DVT, EV0001, Qty 1

THERMOTEK, INC.

Single-chamber venous compression system garment, single-use

• Primary Device ID: 00850033615005
• NIH Device Record Key: 03bd0189-4562-4958-8766-d28bd103c27f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Evolution 2
• Version Model Number: 0V12X1009M01
• Catalog Number: 0V12X1009M01
• Company DUNS: 847899911
• Company Name: THERMOTEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 972-874-4949
• Email: slee@thermotekusa.com
• Phone: 972-874-4949
• Email: slee@thermotekusa.com
• Phone: 972-874-4949
• Email: slee@thermotekusa.com
• Phone: 972-874-4949
• Email: slee@thermotekusa.com
• Phone: 972-874-4949
• Email: slee@thermotekusa.com
• Phone: 972-874-4949
• Email: slee@thermotekusa.com
• Phone: 972-874-4949
• Email: slee@thermotekusa.com
• Phone: 972-874-4949
• Email: slee@thermotekusa.com
• Phone: 972-874-4949
• Email: slee@thermotekusa.com
• Phone: 972-874-4949
• Email: slee@thermotekusa.com
• Phone: 972-874-4949
• Email: slee@thermotekusa.com
• Phone: 972-874-4949
• Email: slee@thermotekusa.com
• Phone: 972-874-4949
• Email: slee@thermotekusa.com
• Phone: 972-874-4949
• Email: slee@thermotekusa.com
• Phone: 972-874-4949
• Email: slee@thermotekusa.com
• Phone: 972-874-4949
• Email: slee@thermotekusa.com
• Phone: 972-874-4949
• Email: slee@thermotekusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850033615005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160318

FDA Product Code

• JOW: Sleeve, Limb, Compressible

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-30
• Device Publish Date: 2023-08-22

Devices Manufactured by THERMOTEK, INC.

• 00850033615005 - Evolution 2: 2023-08-30Evolution, DVT, EV0001, Qty 1
• 00850033615005 - Evolution 2: 2023-08-30 Evolution, DVT, EV0001, Qty 1
• 00850033615012 - ARTEK SPORT-01 w UNIV-01, Qty 1: 2023-03-09 ARTEK SPORT-01 w UNIV-01, Qty 1
• 00850033615036 - ArTek Sport Wrap: 2023-03-09 Wrap, ArTek Sport,Univ-01,Qty 1
• 00850033615050 - ARTEK PRO-01 WRAP: 2023-03-09 WRAP, ARTEK PRO-01, UNV COMP01
• 00850033615067 - ARTEK PRO-01: 2023-03-09 ARTEK PRO-01 W/UNV WRAP, COMP01
• B5850P9PT09SYS0 - PT9: 2019-03-12 PT9 Therapy System
• B5850P9PTVT4000 - VascuTherm4: 2019-03-12 VascuTherm4 Therapy System
• B5850P9PTVT5000 - VascuTherm5: 2019-03-12 VascuTherm5 Therapy System