Identity
- Trade Name
- PERF-GEN Pulsatile Perfusion Solution FDA UDI
- Generic Name
- Donor-organ/tissue/cell preservation solution FDA UDI
- Device Name
- Clear, sterile, non-pyrogenic solution intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient. FDA UDI
- Model / Reference
- PERF-GEN/1000/US FDA UDI
- Description
- Clear, sterile, non-pyrogenic solution intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 13700911900492 FDA UDI
- 510(k) Number
- K221386 FDA UDI
- FDA Product Code
- KDL 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
PERF-GEN Pulsatile Perfusion Solution by Institut Georges Lopez — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Donor-organ/tissue/cell preservation solution.
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- STEEN Solution™ — XVIVO PERFUSION, INC. · Class III
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- X°Port Lung Preservation Solution — Traferox Technologies, Inc. · Class II
Cleared under the same submission
K221386 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
- Institut Georges Lopez
Sources (1)
- FDA UDI c079104f-347c-4323-a3b1-170012f7b034 35 fields · synced Jun 1, 2026