23.401

Organization name

XVIVO B.V.

SRN

NL-MF-000018307

Manufacturer status

—

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

• CW999

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

  The Kidney Assist Transport Perfusion Set is to be used exclusively in combination with the Kidney Assist Transport (REF 23.101) and an approved machine perfusion solution.
• CW032

  Check the expiry date on the Kidney Assist Transport Perfusion Set. Do not use if the date has expired.
• 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 Transport Perfusion Set is damaged, or even if there is the slightest doubt regarding the sterility of the product.
• CW999

  Before using the Kidney Assist Transport Perfusion Set a careful visual and, if thought necessary, a functional control should be made to exclude possible damages from irregular transport-/storage conditions.
• CW999

  Due to sterilization procedure the Luer Lock connectors loosen and must be tightened again before application. Tubes and Luer Lock connections must be fixed and fastened only by hand. Other aids can damage the connectors.
• CW999

  Do not tap the oxygenator and pump head with hard tools during priming procedure.
• CW999

  Application of the Kidney Assist Transport Perfusion Set must be made under aseptic conditions.
• CW999

  The minimum operating volume in the Kidney Assist Transport Perfusion Set reservoir is 1000 ml.
• CW999

  The Kidney Assist Transport Perfusion Set must be used immediately after opening the wrapping.
• CW009

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

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

  Dispose the used Kidney Assist Transport Perfusion Set according to the valid regulations in your country.
• CW999

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

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

Primary placement in Netherlands; available across 15 countries total.

Trade name

not provided

UDI-DI code

08719925460524

Basic UDI-DI

871992546400MH

Reference / catalog number

23.401

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 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