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WCM Cassette (included in WCM cassettes kit) - 1/sterile bag
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- WCM Cassette (included in WCM cassettes kit) - 1/sterile bag FDA UDI
- Generic Name
- Kidney donor-organ preservation/transport perfusion set FDA UDI
- Device Name
- The cassette is a self-contained circulation system consisting of an organ chamber, a venous and arterial reservoir, a bubble trap, a membrane oxygenator, a heat exchanger and pulsatile pump head. The system can provide circulation of one liter of PPS (machine perfusate) to one kidney. The kidney is attached to the arterial ports either in single fashion, or can be placed enbloc. FDA UDI
- Model / Reference
- WCM Cassette FDA UDI
- Description
- The cassette is a self-contained circulation system consisting of an organ chamber, a venous and arterial reservoir, a bubble trap, a membrane oxygenator, a heat exchanger and pulsatile pump head. The system can provide circulation of one liter of PPS (machine perfusate) to one kidney. The kidney is attached to the arterial ports either in single fashion, or can be placed enbloc. FDA UDI
Identifiers
- Catalog Number
- 3930005.014 FDA UDI
- Primary DI / UDI-DI
- B154W39300050110 FDA UDI
- 510(k) Number
- K111521 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
- Not 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
No
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
WCM Cassette (included in WCM cassettes kit) - 1/sterile bag by Waters Medical Systems, LLC — Class II — FDA UDI — listed in FDA GUDID
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
- Waters Medical Systems, LLC
Sources (1)
- FDA UDI 02db59ad-011f-4d97-81f9-f2a98c422480 37 fields · synced Jun 9, 2026