FDA.reportPublic FDA data

PleuraFlow® ZIP

Primary DI
00856449006161
Brand
PleuraFlow® ZIP
Company
Clearflow, Inc.
Model
PF-ZIP 1.5
Device description
The ZIP, Accessory Shuttle for PleuraFlow® System
Published
2019-08-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
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
00856449006161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856449006161008564490061618564490061610856449006161

GMDN Terms#

Term, Definition table
TermDefinition
Mediastinal drainage catheterA sterile, tube designed to establish a channel for the removal of fluid or purulent material from the mediastinum (the central compartment of the thoracic cavity); it is not coated with an antimicrobial agent. It is typically used in conjunction with, or as a component of, a drainage system that uses a low negative pressure through the drain lumen. It is typically made of silicone, available in various designs, shapes, and sizes, and may include disposable devices dedicated to catheter introduction; it does not include any fluid collection bags/containers. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
827428223
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
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