Home GUDID 00816305020588 Flexitouch
Primary DI 00816305020588
Brand Flexitouch
Company TACTILE SYSTEMS TECHNOLOGY, INC.
Model U-CH-S4-R
Published 2016-09-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name JOW Sleeve, Limb, Compressible
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JOW Sleeve, Limb, Compressible Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816305020588 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00816305020588 00816305020588 816305020588 0816305020588
GMDN Terms# Term, Definition table Term Definition Multi-chamber venous compression system garment, reusable An inflatable device in the form of a stocking, sleeve, or suit that is applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the sequential inflation of several chambers. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk. This is a reusable device.
Regulatory Flags# DUNS number 146295980 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04719893351026 Wellell Wellell Inc. JOW 2026-03-17 00812311022363 BIOARTERIAL+ Bio Compression Systems, Inc JOW 2026-03-09 00850033615272 ThermoTek WRAP, DVT, CALF SET, PUSH, SPU THERMOTEK, INC. JOW 2026-02-21 00850033615494 ThermoTek WRAP,DVT,CA,SET,PUSH,SPU, QTY 10, CTN THERMOTEK, INC. JOW 2026-02-21 00812311022479 Bio Arterial Deluxe Bio Compression Systems, Inc JOW 2026-02-13 00850001096386 Therm-X ZENITH TECHNICAL INNOVATIONS, LLC JOW 2026-02-13 00850001096393 Therm-X ZENITH TECHNICAL INNOVATIONS, LLC JOW 2026-02-13 00850001096409 Therm-X ZENITH TECHNICAL INNOVATIONS, LLC JOW 2026-02-13 00850001096416 Therm-X ZENITH TECHNICAL INNOVATIONS, LLC JOW 2026-02-13 00850001096423 Therm-X ZENITH TECHNICAL INNOVATIONS, LLC JOW 2026-02-13 00850001096430 Therm-X ZENITH TECHNICAL INNOVATIONS, LLC JOW 2026-02-13 00850001096447 Therm-X ZENITH TECHNICAL INNOVATIONS, LLC JOW 2026-02-13 00850001096461 Therm-X ZENITH TECHNICAL INNOVATIONS, LLC JOW 2026-02-13 00850001096478 Therm-X ZENITH TECHNICAL INNOVATIONS, LLC JOW 2026-02-13 00850001096485 Therm-X ZENITH TECHNICAL INNOVATIONS, LLC JOW 2026-02-13 00850001096492 Therm-X ZENITH TECHNICAL INNOVATIONS, LLC JOW 2026-02-13 00850001096508 Therm-X ZENITH TECHNICAL INNOVATIONS, LLC JOW 2026-02-13 00850001096522 Therm-X ZENITH TECHNICAL INNOVATIONS, LLC JOW 2026-02-13 00850001096539 Therm-X ZENITH TECHNICAL INNOVATIONS, LLC JOW 2026-02-13 00850001096546 Therm-X ZENITH TECHNICAL INNOVATIONS, LLC JOW 2026-02-13 00850001096553 Therm-X ZENITH TECHNICAL INNOVATIONS, LLC JOW 2026-02-13 10885380185120 Kendall Cardinal Health 200, LLC JOW 2026-02-10 18809802648491 DVT-SERIES DAESUNG MAREF CO.,LTD. JOW 2026-02-09 18809802648507 DVT-SERIES DAESUNG MAREF CO.,LTD. JOW 2026-02-09 10816317024427 Kendall DVT Sleeve RENU MEDICAL, INC JOW 2026-01-27 10816317024434 Kendall DVT Sleeve RENU MEDICAL, INC JOW 2026-01-27 10816317024441 Kendall DVT Sleeve RENU MEDICAL, INC JOW 2026-01-27 00850031012615 AIROS AIROS MEDICAL INC JOW 2026-01-23 10850031012629 AIROS AIROS MEDICAL INC JOW 2026-01-23 10850031012636 AIROS AIROS MEDICAL INC JOW 2026-01-23