21.401

Organization name

XVIVO B.V.

SRN

NL-MF-000018307

Manufacturer status

—

9 warnings recorded — scroll inside the panel to see all entries.

• CW007

  The product is sterile in the unopened and undamaged packaging. Carefully inspect the product for breaches of the integrity of the packaging. Do not use if the packaging or Kidney Assist Perfusion Set is damaged, or even if there is the slightest doubt regarding the sterility of the product.
• CW032

  Check the expiry date on the Kidney Assist Perfusion Set. Do not use if the date has expired.
• CW009

  The Kidney Assist Perfusion Set is for single use only and may not be re-used or re-sterilized.
• CW999

  XVIVO is not responsible for any damage caused operating the device outside the intended use.
• CW999

  Modifications, especially post-treatments of the Kidney Assist Perfusion Set is not allowed; they would affect safety and lead to exclusion of liability.
• CW999

  Please contact XVIVO directly with any complaint at: qa.xnl@xvivogroup.com
• CW999

  Safe use of the Kidney Assist can only be guaranteed when the operator is a skilled and trained professional and has successfully followed a Kidney Assist training course.
• CW999

  Any serious incident that has occurred in relation to Kidney Assist should be reported to XVIVO and the competent authority of the Member State in which the user and/or patient is established.
• CW999

  Do not tap the oxygenator and pump head with hard tools during priming procedure.

Primary placement in Netherlands; available across 10 countries total.

Trade name

not provided

UDI-DI code

08719925460722

Basic UDI-DI

871992546400MH

Reference / catalog number

21.401

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

For oxygenated hypothermic and normothermic perfusion of donor kidneys.

Additional information URL

https://www.xvivogroup.com/resource-type/instructions-for-use/

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.

• C0399CARDIOSURGERY AND ORGAN TRANSPLANTATION DEVICES - OTHER