RCI VAK Wound Drainage Pump - The Exsudex® Wound Drainage Device is a compact, - Meditop B.V.

Duns Number:387209518

Device Description: The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients wh

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More Product Details

Catalog Number

3000700-RCIVAK

Brand Name

RCI VAK Wound Drainage Pump

Version/Model Number

XL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 14, 2018

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

-

Product Code Name

-

Device Record Status

Public Device Record Key

c97d0574-182d-4f6e-87e3-0a20e3f3642b

Public Version Date

November 23, 2021

Public Version Number

4

DI Record Publish Date

January 26, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDITOP B.V." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9