Exsudex Wound Drainage pump 3000800

GUDID 08718104890008

The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients who would benefit from the application of negative pressure to the area of a wound, for the aspiration and removal of surgical fluids, irrigation fluids, tissue (including bone), gases, bodily fluids or infectious materials either during surgery or at the patient’s bedside particularly as the device may promote wound healing.

Meditop B.V.

Negative-pressure wound therapy system, electric, reusable
Primary Device ID08718104890008
NIH Device Record Key03fafb5b-c4e0-4454-a37a-dd87175ea47d
Commercial Distribution StatusIn Commercial Distribution
Brand NameExsudex Wound Drainage pump
Version Model NumberXS
Catalog Number3000800
Company DUNS387209518
Company NameMeditop B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+31348566100
Emailinfo@meditop.nl
Phone+31348566100
Emailinfo@meditop.nl
Phone+31348566100
Emailinfo@meditop.nl
Phone+31348566100
Emailinfo@meditop.nl
Phone+31348566100
Emailinfo@meditop.nl
Phone+31348566100
Emailinfo@meditop.nl
Phone+31348566100
Emailinfo@meditop.nl
Phone+31348566100
Emailinfo@meditop.nl
Phone+31348566100
Emailinfo@meditop.nl
Phone+31348566100
Emailinfo@meditop.nl
Phone+31348566100
Emailinfo@meditop.nl
Phone+31348566100
Emailinfo@meditop.nl
Phone+31348566100
Emailinfo@meditop.nl
Phone+31348566100
Emailinfo@meditop.nl
Phone+31348566100
Emailinfo@meditop.nl
Phone+31348566100
Emailinfo@meditop.nl

Operating and Storage Conditions

Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 85 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 85 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 85 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 85 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 85 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 85 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 85 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 85 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 85 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 85 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 85 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 85 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 85 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 85 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 85 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 85 KiloPascal and 110 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS108718104890008 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-11-23
Device Publish Date2016-10-26

On-Brand Devices [Exsudex Wound Drainage pump]

87181048900152The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients who wou
87181048900084The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients who wou
08718104890015The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients who wou
08718104890008The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients who wou

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