FDA.reportPublic FDA data

PleuraFlow® POD

Primary DI
00856449006130
Brand
PleuraFlow® POD
Company
Clearflow, Inc.
Model
PFPD-7515
Device description
High Capacity Dry Thoracic Drainage Pod-2400 mL Dual Chamber
Published
2018-07-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDQBottle, Collection, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856449006137PackageGS15Not in Commercial Distribution
00856449006130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085644900613710856449006137
00856449006130008564490061308564490061300856449006130

GMDN Terms#

Term, Definition table
TermDefinition
Thoracic suction collection containerA device intended to be connected between a thoracic drainage catheter (not included) and a suction wall outlet, to collect fluids (e.g., blood), secretions and/or air during controlled aspiration of the pleural cavity and/or mediastinum. The device typically incorporates three graduated chambers, designed for fluid collection, water seal, and suction control, and a suction regulator, air leak indicator, and connection tubing. This is a single-use device.

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
Premarket exempt
true
Lot or batch
true
Expiration date on label
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
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

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Primary DI, Brand, Company table
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14026704937292PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
14026704937353PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
00628725095363Pleural Drain Dry Seal System CHS USA Inc.KDQ2026-04-17
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