FDA.reportPublic FDA data

PleuraFlow® System with FlowGlide

Primary DI
00856449006048
Brand
PleuraFlow® System with FlowGlide
Company
Clearflow, Inc.
Model
PF-20 SEDL
Device description
PF-20 SEDL PleuraFlow® System with FlowGlide
Published
2016-09-23
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
GBXCatheter, Irrigation
OTKWound Drain Catheter System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1
OTKWound Drain Catheter SystemGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153681000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153681000PleuraFlow SystemClearflow, Inc.2016-01-20OTK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856449006045PackageGS110In Commercial Distribution
20856449006042PackageGS11In Commercial Distribution
00856449006048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085644900604510856449006045
2085644900604220856449006042
00856449006048008564490060488564490060480856449006048

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drain, non-bioabsorbableA tube-like, non-bioabsorbable 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 variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any 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 and humidity

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
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
00856449006222Pleuraflow® System with FlowGlidePFFG3-20 XDL2021-03-09
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
10080196995998MEDLINEMEDLINE INDUSTRIES, INC.GBX2024-12-12
10080196128839MedlineMEDLINE INDUSTRIES, INC.GBX2023-12-27
10080196997633MedlineMEDLINE INDUSTRIES, INC.GBX2023-12-27
10801902210408ARROWTELEFLEX INCORPORATEDGBX2022-11-09
10801902194005ARROWTELEFLEX INCORPORATEDGBX2022-11-08
08034139292823Thoracic Catheter, Straight Fr 18REDAX SPAGBX2021-05-07
08034139292830Thoracic Catheter, Straight Fr 21REDAX SPAGBX2021-05-07
08034139292847Thoracic Catheter, Straight Fr 24REDAX SPAGBX2021-05-07
08034139292861Thoracic Catheter, Straight Fr 30REDAX SPAGBX2021-05-07
08034139292878Thoracic Catheter, Straight Fr 33REDAX SPAGBX2021-05-07
08034139293806Thoracic Catheter, Angled Fr 30REDAX SPAGBX2021-05-07
08034139293813Thoracic Catheter, Angled Fr 33REDAX SPAGBX2021-05-07
08034139294544Flat Drain 3/4 type Jackson-Pratt 4x10 mmREDAX SPAGBX2021-05-07
08034139294568Flat Drain type Jackson-Pratt 4x10 mmREDAX SPAGBX2021-05-07
08034139294575Flat Drain type Jackson-Pratt w/trocar 4x10 mmREDAX SPAGBX2021-05-07
08034139294582Flat Drain type Jackson-Pratt 4x13 mmREDAX SPAGBX2021-05-07
08034139294599Flat Drain type Jackson-Pratt w/trocar 4x13 mmREDAX SPAGBX2021-05-07
08034139294629Round Drain type Jackson-Pratt Fr 7REDAX SPAGBX2021-05-07
08034139294643Round Drain type Jackson-Pratt Fr 10REDAX SPAGBX2021-05-07
08034139294650Round Drain type Jackson-Pratt w/trocar Fr 10REDAX SPAGBX2021-05-07
08034139294698Round Drain type Jackson-Pratt w/trocar Fr 15REDAX SPAGBX2021-05-07
08034139294933Spiral Drain Round Fluted Drain w/trocar Fr 10REDAX SPAGBX2021-05-07
08034139294940Spiral Drain Round Fluted Drain w/trocar Fr 15REDAX SPAGBX2021-05-07
08034139294964Spiral Drain Round Fluted Drain w/trocar Fr 12REDAX SPAGBX2021-05-07
08034139294971Spiral Drain Round Fluted Drain Fr 7REDAX SPAGBX2021-05-07
08034139295008Spiral Drain Round Fluted Drain Fr 10REDAX SPAGBX2021-05-07
08034139295022Spiral Drain Round Fluted Drain Fr 15REDAX SPAGBX2021-05-07
08034139295039Spiral Drain Round Fluted Drain Fr 19REDAX SPAGBX2021-05-07
08034139295053Spiral Drain Round Fluted Drain Fr 24REDAX SPAGBX2021-05-07
08034139295060Flat Fluted Drain 4x10 mmREDAX SPAGBX2021-05-07