IRRAflow® Drainage Collection System DCS 010

GUDID 10868643000477

DCS 010 Drainage Collection System

IRRAS USA

Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term
Primary Device ID10868643000477
NIH Device Record Keyad59ad51-42f2-41c6-a19b-984370ab02ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameIRRAflow® Drainage Collection System
Version Model NumberDCS 010
Catalog NumberDCS 010
Company DUNS056999617
Company NameIRRAS USA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100868643000470 [Primary]
GS110868643000477 [Package]
Contains: 00868643000470
Package: Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JXGShunt, Central Nervous System And Components

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10868643000477]

Ethylene Oxide


[10868643000477]

Ethylene Oxide


[10868643000477]

Ethylene Oxide


[10868643000477]

Ethylene Oxide


[10868643000477]

Ethylene Oxide


[10868643000477]

Ethylene Oxide


[10868643000477]

Ethylene Oxide


[10868643000477]

Ethylene Oxide


[10868643000477]

Ethylene Oxide


[10868643000477]

Ethylene Oxide


[10868643000477]

Ethylene Oxide


[10868643000477]

Ethylene Oxide


[10868643000477]

Ethylene Oxide


[10868643000477]

Ethylene Oxide


[10868643000477]

Ethylene Oxide


[10868643000477]

Ethylene Oxide


[10868643000477]

Ethylene Oxide


[10868643000477]

Ethylene Oxide


[10868643000477]

Ethylene Oxide


[10868643000477]

Ethylene Oxide


[10868643000477]

Ethylene Oxide


[10868643000477]

Ethylene Oxide


[10868643000477]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-05-06
Device Publish Date2019-09-30

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10868643000477 - IRRAflow® Drainage Collection System2020-05-06DCS 010 Drainage Collection System
10868643000477 - IRRAflow® Drainage Collection System2020-05-06 DCS 010 Drainage Collection System

Trademark Results [IRRAflow]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IRRAFLOW
IRRAFLOW
87161655 5492869 Live/Registered
Irras AB
2016-09-06

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