Identity
- Trade Name
- LungProtect® FDA UDI
- Generic Name
- Donor-organ/tissue/cell preservation solution FDA UDI
- Device Name
- Container filled with solution for perfusion or preservation of organs intended for transplantation. FDA UDI
- Model / Reference
- 2000 ML FDA UDI
- Description
- Container filled with solution for perfusion or preservation of organs intended for transplantation. FDA UDI
Identifiers
- Catalog Number
- LPRT2000 FDA UDI
- Primary DI / UDI-DI
- 05906874879092 FDA UDI
- 510(k) Number
- K240650 FDA UDI
- FDA Product Code
- KDN FDA UDI
- GMDN Term
- Donor-organ/tissue/cell preservation solution 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: Donor-organ/tissue/cell preservation solution
LungProtect® by Carnamedica Sp Z O O — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Donor-organ/tissue/cell preservation solution.
- Custodiol(R) — Dr. Franz Köhler Chemie GmbH · Class II
- Custodiol(R) — Dr. Franz Köhler Chemie GmbH · Class II
- Custodiol — Dr. Franz Köhler Chemie GmbH · Class II
- Belzer MPS (UW Machine Perfusion Solution ) — PRESERVATION SOLUTIONS, INC. · Class II
- X°Port Lung Preservation Solution — Traferox Technologies, Inc. · Class II
- STEEN Solution™ — XVIVO PERFUSION, INC. · Class III
- Custodiol(R) — Dr. Franz Köhler Chemie GmbH · Class II
- PARAGON-W (UW solution) — INSTITUT GEORGES LOPEZ · Class II
Cleared under the same submission
K240650 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
- Carnamedica Sp Z O O
Sources (1)
- FDA UDI 87215d19-109f-43d5-a808-f80ad01510c7 36 fields · synced May 29, 2026