Zenso

Organization name

Oxmed International BV

SRN

NL-MF-000025538

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Netherlands; available across 1 country total.

Placed on the market in Netherlands; per-country availability dates not published.

Trade name

Zenso

UDI-DI code

08720795808149

Basic UDI-DI

87207958ZS-WM25

Reference / catalog number

Z30B10XA

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

10

Additional product description

Zenso wound and fistula pouch 10mm (110x75mm) tap velcro acces panel: The Zenso wound and fistula pouch is for use in draining and collecting output from wounds, stomas, particularly high output difficult to manage stomas and fistulae. Their use where post-operative wounds require drainage and nursing management following surgery allows the healthcare professional to cover the affected area while still being able to drain it of exudate, carry out other care or simply cover over the area during palliative care. The smaller sizes are for use where collection of exudate is required. Zenso wound and fistula pouch may be applied by healthcare professionals or by the patient/user following training by their healthcare professional. The Zenso wound and fistula pouch has no healing or treatment properties and is only intended for adhesion to intact skin. The Zenso wound and fistula pouch is a range of 1-piece pouches in various sizes and shapes. All pouches feature a skin friendly hydrocolloid wafer for adhesion to the body and this is protected before use with a release film that shows a cutting guide. Pouches are manufactured from odour barrier film with a comfort non-woven layer. All pouches carry a tap for easy drainage and most pouches have a roll up drain port secured with an integral ‘velcro’ type closure. Some pouches feature a vent with lid for venting the pouch or rinsing the wound area if required. All pouches have a transparent film to inspect the stoma if needed and some pouches have an access panel for nursing care.The Zenso wound and fistula pouch is latex-free and does not contain ingredients of animal origin.

Additional information URL

https://oxmed.com/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• A060301COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE