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

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
10856449006236PackageGS110In Commercial Distribution
20856449006233PackageGS11In Commercial Distribution
00856449006239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085644900623610856449006236
2085644900623320856449006233
00856449006239008564490062398564490062390856449006239

GMDN Terms#

Term, Definition table
TermDefinition
Pleural catheterA 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
TypeValueUnit
Catheter Gauge24French

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
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10856449006175Pleuraflow® System with FlowGlidePFFG3-202021-03-09
10856449006182Pleuraflow® System with FlowGlidePFFG3-242021-03-09
10856449006199Pleuraflow® System with FlowGlidePFFG3-282021-03-09
10856449006205Pleuraflow® System with FlowGlidePFFG3-322021-03-09
10856449006229Pleuraflow® System with FlowGlidePFFG3-20 XDL2021-03-09
10856449006243Pleuraflow® System with FlowGlidePFFG3-24 RA2021-03-09
10856449006250Pleuraflow® System with FlowGlidePFFG3-28 RA2021-03-09
10856449006267Pleuraflow® System with FlowGlidePFFG3-32 RA2021-03-09
20856449006110PleuraFlow® System with FlowGlidePFFG-24 RA2019-07-10
20856449006127PleuraFlow® System with FlowGlidePFFG-28 RA2019-04-02
20856449006011PleuraFlow® SystemPF-242016-09-23
10856449006021PleuraFlow® SystemPF-282016-09-23
10856449006045PleuraFlow® System with FlowGlidePF-20 SEDL2016-09-23
20856449006059PleuraFlow® System with FlowGlidePFFG-202017-04-17
20856449006066PleuraFlow® System with FlowGlidePFFG-242017-04-17
20856449006073PleuraFlow® System with FlowGlidePFFG-282017-04-17
20856449006080PleuraFlow® System with FlowGlidePFFG-322017-04-17
20856449006103PleuraFlow® System with FlowGlidePFFG-24 XDL2018-09-01
10856449006137PleuraFlow® PODPFPD-75152018-07-01

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
00856449006222Pleuraflow® 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
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