PleuraFlow® System

GUDID 20856449006011

PF-24 PleuraFlow® System

ClearFlow

Closed-wound drain
Primary Device ID20856449006011
NIH Device Record Keyb4be03bd-8882-4fd8-986f-0eb68132b3d2
Commercial Distribution Discontinuation2018-12-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePleuraFlow® System
Version Model NumberPF-24
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 Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity
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 and humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100856449006017 [Primary]
GS110856449006014 [Package]
Contains: 00856449006017
Package: Inner Package [10 Units]
Discontinued: 2018-12-21
Not in Commercial Distribution
GS120856449006011 [Package]
Contains: 10856449006014
Package: Case [1 Units]
Discontinued: 2018-12-21
Not in Commercial Distribution

FDA Product Code

OTKWound Drain Catheter System

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20856449006011]

Ethylene Oxide


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Ethylene Oxide


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Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


[20856449006011]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-25
Device Publish Date2016-09-23

On-Brand Devices [PleuraFlow® System]

00856449006031PF-32 PleuraFlow® System
10856449006021PF-28 PleuraFlow® System
20856449006011PF-24 PleuraFlow® System
00856449006000PF-20 PleuraFlow® System

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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