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Kidney Assist Transport

FDA UDI

Class II (US FDA UDI)

by Xvivo B.v.

Identity

Trade Name
Kidney Assist Transport FDA UDI
Generic Name
Kidney donor-organ preservation/transport system FDA UDI
Device Name
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. FDA UDI
Model / Reference
Kidney Assist Transport FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
23.101 FDA UDI
Primary DI / UDI-DI
08719925460517 FDA UDI
510(k) Number
K211333 FDA UDI
FDA Product Code
KDN FDA UDI
GMDN Term
Kidney donor-organ preservation/transport system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5880 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Kidney donor-organ preservation/transport system

Kidney Assist Transport by Xvivo B.v. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K211333 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Xvivo B.v.

Sources (1)

  • FDA UDI 0bf747b9-fd1a-4892-b6e0-c3234dbf16d1 37 fields · synced Jun 8, 2026