Home GUDID 00389701007922 GLIDEACCESS
Primary DI 00389701007922
Brand GLIDEACCESS
Company TERUMO MEDICAL CORPORATION
Model RSM05
Catalog number RSM05
Device description GLIDEACCESS System Percutaneous Sheath Introducer Kit
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name DQX WIRE, GUIDE, CATHETER DWS Instruments, Surgical, Cardiovascular DYB INTRODUCER, CATHETER
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQX Wire, Guide, Catheter Cardiovascular 2 DWS Instruments, Surgical, Cardiovascular Cardiovascular 1 DYB Introducer, Catheter Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30389701007923 Package GS1 10 In Commercial Distribution 50389701007927 Package GS1 10 In Commercial Distribution 00389701007922 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 30389701007923 30389701007923 50389701007927 50389701007927 00389701007922 00389701007922 389701007922 0389701007922
GMDN Terms# Term, Definition table Term Definition Vascular catheter introduction set, nonimplantable A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator and/or a vascular catheter introduction needle (e.g., arterial needle), and typically an additional access device(s) [e.g., guidewire, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually for arterial access; some sets include in addition noninvasive supportive devices (e.g., drapes, dressings). This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 0 Device Size Text, specify 0 Length 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Avoid direct sunlight Special Storage Condition, Specify 0 0 Do not store at extreme temperature and humidity
Regulatory Flags# DUNS number 131489882 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 true Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 B382SD903260200 Surgical Direct Surgical Direct, Inc. DWS 2026-10-28 00198715836998 EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING FREUDENBERG MEDICAL, LLC DYB 2026-01-29 00194613032715 MSI Precision Specialty Instruments Med Saver, Inc. DWS 2025-08-01 00389701009261 PINNACLE TERUMO MEDICAL CORPORATION DYB 2018-03-21 00382903840120 BD Introsyte Autoguard BECTON, DICKINSON AND COMPANY DYB 2016-10-20 00382903840083 BD Introsyte-N Autoguard, BD Instaflash BECTON, DICKINSON AND COMPANY DYB 2016-10-20 00382903840106 BD Introsyte Autoguard BECTON, DICKINSON AND COMPANY DYB 2016-10-20 00382903840113 BD Introsyte Autoguard BECTON, DICKINSON AND COMPANY DYB 2016-10-20 00389701006161 DESTINATION TERUMO MEDICAL CORPORATION DYB 2016-09-24 00389701006178 DESTINATION TERUMO MEDICAL CORPORATION DYB 2016-09-24 00389701006185 DESTINATION TERUMO MEDICAL CORPORATION DYB 2016-09-24 00389701006192 DESTINATION TERUMO MEDICAL CORPORATION DYB 2016-09-24 00389701006208 DESTINATION TERUMO MEDICAL CORPORATION DYB 2016-09-24 00389701006215 DESTINATION TERUMO MEDICAL CORPORATION DYB 2016-09-24 00389701006222 DESTINATION TERUMO MEDICAL CORPORATION DYB 2016-09-24 00389701006239 DESTINATION TERUMO MEDICAL CORPORATION DYB 2016-09-24 00389701006246 DESTINATION TERUMO MEDICAL CORPORATION DYB 2016-09-24 00389701006253 DESTINATION TERUMO MEDICAL CORPORATION DYB 2016-09-24 00389701006260 DESTINATION TERUMO MEDICAL CORPORATION DYB 2016-09-24 00389701006277 DESTINATION TERUMO MEDICAL CORPORATION DYB 2016-09-24 00389701006796 DESTINATION TERUMO MEDICAL CORPORATION DYB 2016-09-24 00389701006802 DESTINATION TERUMO MEDICAL CORPORATION DYB 2016-09-24 00389701006970 DESTINATION TERUMO MEDICAL CORPORATION DYB 2016-09-24 00389701006987 DESTINATION TERUMO MEDICAL CORPORATION DYB 2016-09-24 00389701006994 DESTINATION TERUMO MEDICAL CORPORATION DYB 2016-09-24 00389701007007 DESTINATION TERUMO MEDICAL CORPORATION DYB 2016-09-24 00389701007168 DESTINATION TERUMO MEDICAL CORPORATION DYB 2016-09-24 00389701007175 DESTINATION TERUMO MEDICAL CORPORATION DYB 2016-09-24 00389701007182 DESTINATION TERUMO MEDICAL CORPORATION DYB 2016-09-24 00389701007199 DESTINATION TERUMO MEDICAL CORPORATION DYB 2016-09-24