PleuraFlow® System with FlowGlide

GUDID 00856449006147

PFFG-32 RA PleuraFlow® System with FlowGlide™

ClearFlow

Mediastinal drainage catheter
Primary Device ID00856449006147
NIH Device Record Key9ca5cea8-2dcf-49f2-90b0-f65cd0038cd0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePleuraFlow® System with FlowGlide
Version Model NumberPFFG-32 RA
Company DUNS827428223
Company NameClearFlow
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com
Phone844-257-3569
Emailcustomerservice@clearflow.com

Device Dimensions

Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French
Catheter Gauge32 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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
Special Storage Condition, SpecifyBetween 0 and 0 *Handle 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100856449006147 [Primary]
GS110856449006144 [Package]
Package: Inner Pack [10 Units]
In Commercial Distribution
GS120856449006141 [Package]
Contains: 10856449006144
Package: Case [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OTKWound Drain Catheter System

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00856449006147]

Ethylene Oxide


[00856449006147]

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[00856449006147]

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[00856449006147]

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[00856449006147]

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[00856449006147]

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[00856449006147]

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[00856449006147]

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[00856449006147]

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[00856449006147]

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[00856449006147]

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[00856449006147]

Ethylene Oxide


[00856449006147]

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Ethylene Oxide


[00856449006147]

Ethylene Oxide


[00856449006147]

Ethylene Oxide


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Ethylene Oxide


[00856449006147]

Ethylene Oxide


[00856449006147]

Ethylene Oxide


[00856449006147]

Ethylene Oxide


[00856449006147]

Ethylene Oxide


[00856449006147]

Ethylene Oxide


[00856449006147]

Ethylene Oxide


[00856449006147]

Ethylene Oxide


[00856449006147]

Ethylene Oxide


[00856449006147]

Ethylene Oxide


[00856449006147]

Ethylene Oxide


[00856449006147]

Ethylene Oxide


[00856449006147]

Ethylene Oxide


[00856449006147]

Ethylene Oxide


[00856449006147]

Ethylene Oxide


[00856449006147]

Ethylene Oxide


[00856449006147]

Ethylene Oxide


[00856449006147]

Ethylene Oxide


[00856449006147]

Ethylene Oxide


[00856449006147]

Ethylene Oxide


[00856449006147]

Ethylene Oxide


[00856449006147]

Ethylene Oxide


[00856449006147]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-25
Device Publish Date2019-07-10

On-Brand Devices [PleuraFlow® System with FlowGlide]

20856449006103PFFG-24 XDL PleuraFlow® System with FlowGlide
00856449006093PFFG-20 XDL PleuraFlow® System with FlowGlide
20856449006080PFFG-32 PleuraFlow® System with FlowGlide™
20856449006073PFFG-28 PleuraFlow® System with FlowGlide™
20856449006066PFFG-24 PleuraFlow® System with FlowGlide™
20856449006059PFFG-20 PleuraFlow® System with FlowGlide™
10856449006045PF-20 SEDL PleuraFlow® System with FlowGlide
20856449006127PFFG-28 RA PleuraFlow® System with FlowGlide
00856449006147PFFG-32 RA PleuraFlow® System with FlowGlide™
20856449006110PFFG-24 RA PleuraFlow® System with FlowGlide
10856449006267PFFG3-32 RA Pleuraflow® System with FlowGlide
10856449006250PFFG3-28 RA Pleuraflow® System with FlowGlide
10856449006243PFFG3-24 RA Pleuraflow® System with FlowGlide
10856449006236PFFG3-24 XDL Pleuraflow® System with FlowGlide
10856449006229PFFG3-20 XDL Pleuraflow® System with FlowGlide
10856449006205PFFG3-32 Pleuraflow® System with FlowGlide
10856449006199PFFG3-28 Pleuraflow® System with FlowGlide
10856449006182PFFG3-24 Pleuraflow® System with FlowGlide
10856449006175PFFG3-20 Pleuraflow® System with FlowGlide

Trademark Results [PleuraFlow]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PLEURAFLOW
PLEURAFLOW
77573217 3944788 Live/Registered
CLEARFLOW, INC.
2008-09-18

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