Home GUDID 10856449006021 PleuraFlow® System
Primary DI 10856449006021
Brand PleuraFlow® System
Company ClearFlow
Model PF-28
Device description PF-28 PleuraFlow® System
Published 2016-09-23
Public version status Update
Distribution status Not 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 10856449006021 Package GS1 10 Not in Commercial Distribution 20856449006028 Package GS1 1 Not in Commercial Distribution 00856449006024 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 10856449006021 10856449006021 20856449006028 20856449006028 00856449006024 00856449006024 856449006024 0856449006024
GMDN Terms# Term, Definition table Term Definition Closed-wound drain A sterile, tube-like device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a wide variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, and general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp metal trocar, connector), however it does not include any fluid collection bags/containers. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 28 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 and humidity
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 10856449006236 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
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