Identity
- Trade Name
- LifePort® Kidney Transporter FDA UDI
- Generic Name
- Kidney donor-organ preservation/transport perfusion set FDA UDI
- Device Name
- LifePort® Kidney Transporter Perfusion Circuit FDA UDI
- Model / Reference
- LKT201 FDA UDI
- Description
- LifePort® Kidney Transporter Perfusion Circuit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815045020377 FDA UDI
- 510(k) Number
- K021362 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
No
FDA UDI
Category: Kidney donor-organ preservation/transport perfusion set
LifePort® Kidney Transporter by Organ Recovery Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Kidney donor-organ preservation/transport perfusion set.
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- Perfusion Coupler — INSTITUT GEORGES LOPEZ · Class II
- Perfusion Clamp with Adaptor — INSTITUT GEORGES LOPEZ · Class I
- CANNULA 12MM TEFLON STERILE - 1/packaging — Waters Medical Systems, LLC · Class II
- TA100 TRIPLE ARTERY CANNULA - Sterile - 1/packaging — Waters Medical Systems, LLC · Class II
- CANNULA 14MM TEFLON STERILE - 1/packaging — Waters Medical Systems, LLC · Class II
- Arterial Perfusion Occlusion Clamp — Waters Medical Systems, LLC · Class II
Cleared under the same submission
K021362 also covers:
- LifePort® Kidney Transporter — Organ Recovery Systems, Inc.
- LifePort® Kidney Transporter — Organ Recovery Systems, Inc.
- LifePort® Kidney Transporter — Organ Recovery Systems, Inc.
- LifePort® Kidney Transporter — Organ Recovery Systems, Inc.
- LifePort® Kidney Transporter — Organ Recovery Systems, Inc.
- LifePort® Kidney Transporter — Organ Recovery Systems, Inc.
- LifePort® Kidney Transporter — Organ Recovery Systems, Inc.
- LifePort® Kidney Transporter — Organ Recovery Systems, Inc.
- LifePort® Kidney Transporter — Organ Recovery Systems, Inc.
- LifePort® Kidney Transporter — Organ Recovery Systems, Inc.
- LifePort® Kidney Transporter — Organ Recovery Systems, Inc.
- LifePort® Kidney Transporter — Organ Recovery Systems, Inc.
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
- Organ Recovery Systems, Inc.
Sources (1)
- FDA UDI 9765dd67-54f5-4297-ab77-e2eabfff7b57 35 fields · synced Jun 9, 2026