RCI VAK Wound Drainage Pump 3000700-RCIVAK

GUDID 08718104890060

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, line-powered
Primary Device ID08718104890060
NIH Device Record Keyc97d0574-182d-4f6e-87e3-0a20e3f3642b
Commercial Distribution Discontinuation2018-05-14
Commercial Distribution StatusNot in Commercial Distribution
Brand NameRCI VAK Wound Drainage Pump
Version Model NumberXL
Catalog Number3000700-RCIVAK
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
Phone+31348566100
Emailinfo@meditop.nl

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 85 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
GS108718104890060 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-12-20
Device Publish Date2017-01-26

On-Brand Devices [RCI VAK Wound Drainage Pump]

87181048900602The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients who wou
08718104890060The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients who wou

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