Pleuraflow® System with FlowGlide

Primary DI
00856449006222
Brand
Pleuraflow® System with FlowGlide
Company
Clearflow, Inc.
Model
PFFG3-20 XDL
Device description
PFFG3-20 XDL Pleuraflow® System with FlowGlide
Published
2021-03-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OTKWound Drain Catheter System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OTKWound Drain Catheter SystemGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856449006229PackageGS110In Commercial Distribution
20856449006226PackageGS11In Commercial Distribution
00856449006222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085644900622910856449006229
2085644900622620856449006226
00856449006222008564490062228564490062220856449006222

GMDN Terms#

Term, Definition table
TermDefinition
Pleural catheterA 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
TypeValueUnit
Catheter Gauge20French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Handle 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

Contacts#

Phone, Email table
PhoneEmail
844-257-3569customerservice@clearflow.com

Regulatory Flags#

DUNS number
827428223
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856449006161PleuraFlow® ZIPPF-ZIP 1.52019-08-09
00856449006017PleuraFlow® SystemPF-242016-09-23
00856449006024PleuraFlow® SystemPF-282016-09-23
00856449006048PleuraFlow® System with FlowGlidePF-20 SEDL2016-09-23
00856449006055PleuraFlow® System with FlowGlidePFFG-202017-04-17
00856449006062PleuraFlow® System with FlowGlidePFFG-242017-04-17
00856449006079PleuraFlow® System with FlowGlidePFFG-282017-04-17
00856449006086PleuraFlow® System with FlowGlidePFFG-322017-04-17
00856449006109PleuraFlow® System with FlowGlidePFFG-24 XDL2018-09-01
00856449006116PleuraFlow® System with FlowGlidePFFG-24 RA2019-07-10
00856449006123PleuraFlow® System with FlowGlidePFFG-28 RA2019-04-02
00856449006178Pleuraflow® System with FlowGlidePFFG3-202021-03-09
00856449006185Pleuraflow® System with FlowGlidePFFG3-242021-03-09
00856449006192Pleuraflow® System with FlowGlidePFFG3-282021-03-09
00856449006208Pleuraflow® System with FlowGlidePFFG3-322021-03-09
00856449006239Pleuraflow® System with FlowGlidePFFG3-24 XDL2021-03-09
00856449006246Pleuraflow® System with FlowGlidePFFG3-24 RA2021-03-09
00856449006253Pleuraflow® System with FlowGlidePFFG3-28 RA2021-03-09
00856449006260Pleuraflow® System with FlowGlidePFFG3-32 RA2021-03-09
00856449006147PleuraFlow® System with FlowGlidePFFG-32 RA2019-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00856449006178Pleuraflow® System with FlowGlideClearflow, Inc.OTK2021-03-09
00856449006185Pleuraflow® System with FlowGlideClearflow, Inc.OTK2021-03-09
00856449006192Pleuraflow® System with FlowGlideClearflow, Inc.OTK2021-03-09
00856449006208Pleuraflow® System with FlowGlideClearflow, Inc.OTK2021-03-09
00856449006239Pleuraflow® System with FlowGlideClearflow, Inc.OTK2021-03-09
00856449006246Pleuraflow® System with FlowGlideClearflow, Inc.OTK2021-03-09
00856449006253Pleuraflow® System with FlowGlideClearflow, Inc.OTK2021-03-09
00856449006260Pleuraflow® System with FlowGlideClearflow, Inc.OTK2021-03-09
10856449006175Pleuraflow® System with FlowGlideClearFlowOTK2021-03-09
10856449006182Pleuraflow® System with FlowGlideClearFlowOTK2021-03-09
10856449006199Pleuraflow® System with FlowGlideClearFlowOTK2021-03-09
10856449006205Pleuraflow® System with FlowGlideClearFlowOTK2021-03-09
10856449006229Pleuraflow® System with FlowGlideClearFlowOTK2021-03-09
10856449006236Pleuraflow® System with FlowGlideClearFlowOTK2021-03-09
10856449006243Pleuraflow® System with FlowGlideClearFlowOTK2021-03-09
10856449006250Pleuraflow® System with FlowGlideClearFlowOTK2021-03-09
10856449006267Pleuraflow® System with FlowGlideClearFlowOTK2021-03-09
00856449006161PleuraFlow® ZIPClearflow, Inc.OTK2019-08-09
00856449006116PleuraFlow® System with FlowGlideClearflow, Inc.OTK2019-07-10
20856449006110PleuraFlow® System with FlowGlideClearFlowOTK2019-07-10
00856449006147PleuraFlow® System with FlowGlideClearflow, Inc.OTK2019-07-10
00856449006123PleuraFlow® System with FlowGlideClearflow, Inc.OTK2019-04-02
20856449006127PleuraFlow® System with FlowGlideClearFlowOTK2019-04-02
00856449006109PleuraFlow® System with FlowGlideClearflow, Inc.OTK2018-09-01
00856449006093PleuraFlow® System with FlowGlideClearflow, Inc.OTK2018-09-01
20856449006103PleuraFlow® System with FlowGlideClearFlowOTK2018-09-01
00856449006055PleuraFlow® System with FlowGlideClearflow, Inc.OTK2017-04-17
00856449006062PleuraFlow® System with FlowGlideClearflow, Inc.OTK2017-04-17
00856449006079PleuraFlow® System with FlowGlideClearflow, Inc.OTK2017-04-17
00856449006086PleuraFlow® System with FlowGlideClearflow, Inc.OTK2017-04-17