Identity
- Trade Name
- RM4 Kidney Perfusion System FDA UDI
- Generic Name
- Kidney donor-organ preservation/transport perfusion set FDA UDI
- Device Name
- RM4 Kidney Perfusion System is intended to be used for the pulsatile hypothermic machine perfusion of one or two kidneys for preservation and eventual transplantation into a recipient, only in healthcare professional environment. FDA UDI
- Model / Reference
- RM4 FDA UDI
- Description
- RM4 Kidney Perfusion System is intended to be used for the pulsatile hypothermic machine perfusion of one or two kidneys for preservation and eventual transplantation into a recipient, only in healthcare professional environment. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 13700911900485 FDA UDI
- 510(k) Number
- K211224 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
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 perfusion set
RM4 Kidney Perfusion System by Institut Georges Lopez — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 d158509c-7bbf-4b32-a401-81a0f9f6c246 34 fields · synced May 31, 2026