FDA.reportPublic FDA data

PleuraFlow® System with FlowGlide

Primary DI
00856449006079
Brand
PleuraFlow® System with FlowGlide
Company
Clearflow, Inc.
Model
PFFG-28
Device description
PFFG-28 PleuraFlow® System with FlowGlide™
Published
2017-04-17
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163139000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163139000PleuraFlow System with FlowGlideClearflow, Inc.2016-11-30OTK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856449006076PackageGS110In Commercial Distribution
20856449006073PackageGS11In Commercial Distribution
00856449006079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085644900607610856449006076
2085644900607320856449006073
00856449006079008564490060798564490060790856449006079

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 Gauge28French

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
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
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
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
00856449006086PleuraFlow® System with FlowGlideClearflow, Inc.OTK2017-04-17