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Kidney Assist Transport Perfusion set
FDA UDIClass II (US FDA UDI)
by Xvivo B.v.
Identity
- Trade Name
- Kidney Assist Transport Perfusion set FDA UDI
- Generic Name
- Kidney donor-organ preservation/transport perfusion set 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 Perfusion set 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
- 23.401 FDA UDI
- Primary DI / UDI-DI
- 08719925460524 FDA UDI
- 510(k) Number
- K211333 FDA UDI
- FDA Product Code
- KDN FDA UDI
- GMDN Term
- Kidney donor-organ preservation/transport perfusion set 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Kidney donor-organ preservation/transport perfusion set
Kidney Assist Transport Perfusion set by Xvivo B.v. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Kidney donor-organ preservation/transport perfusion set.
- LifePort® Kidney Transporter — Organ Recovery Systems, Inc. · Class II
- RM3 Accessory Filter — Waters Medical Systems, LLC · Class II
- LifePort® Kidney Transporter — Organ Recovery Systems, Inc. · Class II
- CANNULA 9MM TEFLON STERILE - 1/packaging — Waters Medical Systems, LLC · Class II
- LifePort® Kidney Transporter — Organ Recovery Systems, Inc. · Class II
- Perfusion Coupler — INSTITUT GEORGES LOPEZ · Class II
- LifePort® Kidney Transporter — Organ Recovery Systems, Inc. · Class II
- Perfusion Clamp with Adaptor — INSTITUT GEORGES LOPEZ · Class I
Cleared under the same submission
K211333 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Xvivo B.v.
Sources (1)
- FDA UDI 1134cb52-082b-4c8b-a32d-455069285f13 37 fields · synced May 31, 2026