XVIVO B.V.

Address:Bornholmstraat 84,Groningen,NL

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Perfusion, Kidney (KDN) (2)

Premarket Exempt

Clear

Kidney Assist Transport - 08719925460517 Catalog Number : 23.101

Device Description : The KIDNEY ASSIST-transport is intended to be used for the pulsatile hypothermic The KIDNEY ASSIST-transport is intended to be used for the pulsatile hypothermic oxygenated machineperfusion of kidneys for the preservation, transport, and eventual transplantation into a recipient.

Device Class : 2

Duns Number: 489176113

Premarket Exempt : No

Product Code : KDN

Prescription Use : Yes

Device Count : 1

Kidney Assist Transport Perfusion set - 08719925460524 Catalog Number : 23.401

Device Description : The KIDNEY ASSIST-transport is intended to be used for the pulsatile hypothermic The KIDNEY ASSIST-transport is intended to be used for the pulsatile hypothermic oxygenated machine perfusion of kidneys for the preservation, transport, and eventual transplantation into a recipient.