PT9 0P9PT09SYS

GUDID B5850P9PT09SYS0

PT9 Therapy System

THERMOTEK, INC.

Single-chamber venous compression system garment, reusable Single-chamber venous compression system garment, reusable Single-chamber venous compression system garment, reusable Single-chamber venous compression system garment, reusable Single-chamber venous compression system garment, reusable Single-chamber venous compression system garment, reusable Single-chamber venous compression system garment, reusable Single-chamber venous compression system garment, reusable Single-chamber venous compression system garment, reusable Single-chamber venous compression system garment, reusable Single-chamber venous compression system garment, reusable Single-chamber venous compression system garment, reusable Single-chamber venous compression system garment, reusable Single-chamber venous compression system garment, reusable Single-chamber venous compression system garment, reusable Single-chamber venous compression system garment, reusable Single-chamber venous compression system garment, reusable Single-chamber venous compression system garment, reusable
Primary Device IDB5850P9PT09SYS0
NIH Device Record Key0c01aa92-36cf-4c04-b1be-ae848e9b4ff2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePT9
Version Model Number0P9PT09SYS
Catalog Number0P9PT09SYS
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 Usefalse
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
Emailinfo@thermotekusa.com
Phone972-874-4949
Emailinfo@thermotekusa.com
Phone972-874-4949
Emailinfo@thermotekusa.com
Phone972-874-4949
Emailinfo@thermotekusa.com
Phone972-874-4949
Emailinfo@thermotekusa.com
Phone972-874-4949
Emailinfo@thermotekusa.com
Phone972-874-4949
Emailinfo@thermotekusa.com
Phone972-874-4949
Emailinfo@thermotekusa.com
Phone972-874-4949
Emailinfo@thermotekusa.com
Phone972-874-4949
Emailinfo@thermotekusa.com
Phone972-874-4949
Emailinfo@thermotekusa.com
Phone972-874-4949
Emailinfo@thermotekusa.com
Phone972-874-4949
Emailinfo@thermotekusa.com
Phone972-874-4949
Emailinfo@thermotekusa.com
Phone972-874-4949
Emailinfo@thermotekusa.com
Phone972-874-4949
Emailinfo@thermotekusa.com
Phone972-874-4949
Emailinfo@thermotekusa.com
Phone972-874-4949
Emailinfo@thermotekusa.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB5850P9PT09SYS0 [Primary]

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 Date2019-03-12
Device Publish Date2019-03-04

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 Wrap2023-03-09 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
B5850P9PT09SYS0 - PT92019-03-12PT9 Therapy System
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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