NEWERA II Wound Drainage Pump

FDA UDI

by Meditop B.V.

Identity

Trade Name: NEWERA II Wound Drainage Pump FDA UDI
Generic Name: Negative-pressure wound therapy system, electric, reusable FDA UDI
Device Name: 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. FDA UDI
Model / Reference: XS FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: 3000800-IHT FDA UDI
Primary DI / UDI-DI: 08718104890022 FDA UDI
GMDN Term: Negative-pressure wound therapy system, electric, reusable FDA UDI

Classification

Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

Yes

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Combination Product

FDA UDI

HCT/P

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Premarket Exempt

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Lot / Batch Number

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Serial Number

Yes

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Expiration Date

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Manufacturing Date

Yes

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MRI Safety

MR Unsafe FDA UDI

NEWERA II Wound Drainage Pump by Meditop B.V. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	N/A	Pending data

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Manufacturer

Manufacturer: Meditop B.V.

Sources (1)

FDA UDI ee94b813-0769-4315-9c74-1bee158fcef7 37 fields · synced Jun 8, 2026