Home GUDID 10856449006236 Pleuraflow® System with FlowGlide
Primary DI 10856449006236
Brand Pleuraflow® System with FlowGlide
Company ClearFlow
Model PFFG3-24 XDL
Device description PFFG3-24 XDL Pleuraflow® System with FlowGlide
Published 2021-03-09
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name OTK Wound Drain Catheter System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OTK Wound Drain Catheter System General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10856449006236 Package GS1 10 In Commercial Distribution 20856449006233 Package GS1 1 In Commercial Distribution 00856449006239 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 10856449006236 10856449006236 20856449006233 20856449006233 00856449006239 00856449006239 856449006239 0856449006239
GMDN Terms# Term, Definition table Term Definition Pleural catheter A sterile, tube designed to be inserted through an intercostal space and into the pleural cavity to establish a channel for the removal of fluid (pleural effusion, blood, chyle), air (pneumothorax), or pus (empyema) to permit full expansion of the lungs typically after surgery or chest trauma. It is typically used with a pleural drainage system that uses a low negative pressure through the drain lumen. Often referred to as a chest tube, it is typically made of silicone and is available in various designs, shapes, and sizes; it may include disposable devices dedicated to catheter introduction, however it does not include fluid collection bags/containers. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 24 French
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature, humidity and ultraviolet light
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 827428223 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 true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00856449006178 Pleuraflow® System with FlowGlide Clearflow, Inc. OTK 2021-03-09 00856449006185 Pleuraflow® System with FlowGlide Clearflow, Inc. OTK 2021-03-09 00856449006192 Pleuraflow® System with FlowGlide Clearflow, Inc. OTK 2021-03-09 00856449006208 Pleuraflow® System with FlowGlide Clearflow, Inc. OTK 2021-03-09 00856449006222 Pleuraflow® System with FlowGlide Clearflow, Inc. OTK 2021-03-09 00856449006239 Pleuraflow® System with FlowGlide Clearflow, Inc. OTK 2021-03-09 00856449006246 Pleuraflow® System with FlowGlide Clearflow, Inc. OTK 2021-03-09 00856449006253 Pleuraflow® System with FlowGlide Clearflow, Inc. OTK 2021-03-09 00856449006260 Pleuraflow® System with FlowGlide Clearflow, Inc. OTK 2021-03-09 10856449006175 Pleuraflow® System with FlowGlide ClearFlow OTK 2021-03-09 10856449006182 Pleuraflow® System with FlowGlide ClearFlow OTK 2021-03-09 10856449006199 Pleuraflow® System with FlowGlide ClearFlow OTK 2021-03-09 10856449006205 Pleuraflow® System with FlowGlide ClearFlow OTK 2021-03-09 10856449006229 Pleuraflow® System with FlowGlide ClearFlow OTK 2021-03-09 10856449006243 Pleuraflow® System with FlowGlide ClearFlow OTK 2021-03-09 10856449006250 Pleuraflow® System with FlowGlide ClearFlow OTK 2021-03-09 10856449006267 Pleuraflow® System with FlowGlide ClearFlow OTK 2021-03-09 00856449006161 PleuraFlow® ZIP Clearflow, Inc. OTK 2019-08-09 00856449006116 PleuraFlow® System with FlowGlide Clearflow, Inc. OTK 2019-07-10 20856449006110 PleuraFlow® System with FlowGlide ClearFlow OTK 2019-07-10 00856449006147 PleuraFlow® System with FlowGlide Clearflow, Inc. OTK 2019-07-10 00856449006123 PleuraFlow® System with FlowGlide Clearflow, Inc. OTK 2019-04-02 20856449006127 PleuraFlow® System with FlowGlide ClearFlow OTK 2019-04-02 00856449006109 PleuraFlow® System with FlowGlide Clearflow, Inc. OTK 2018-09-01 00856449006093 PleuraFlow® System with FlowGlide Clearflow, Inc. OTK 2018-09-01 20856449006103 PleuraFlow® System with FlowGlide ClearFlow OTK 2018-09-01 00856449006055 PleuraFlow® System with FlowGlide Clearflow, Inc. OTK 2017-04-17 00856449006062 PleuraFlow® System with FlowGlide Clearflow, Inc. OTK 2017-04-17 00856449006079 PleuraFlow® System with FlowGlide Clearflow, Inc. OTK 2017-04-17 00856449006086 PleuraFlow® System with FlowGlide Clearflow, Inc. OTK 2017-04-17