NEWERA II 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 The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients who would benefit from theapplication 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 thedevice may promote wound healing.

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More Product Details

Catalog Number

3000800-IHT

Brand Name

NEWERA II Wound Drainage Pump

Version/Model Number

XS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 09, 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

ee94b813-0769-4315-9c74-1bee158fcef7

Public Version Date

November 23, 2021

Public Version Number

4

DI Record Publish Date

October 26, 2016

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