Identity
- Trade Name
- DCM-100 DUAL KIDNEY CASSETTE 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 or two kidneys. The kidneys are attached to the arterial ports either in single fashion, or can be placed enbloc. FDA UDI
- Model / Reference
- DCM Kidney 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 or two kidneys. The kidneys are attached to the arterial ports either in single fashion, or can be placed enbloc. FDA UDI
Identifiers
- Catalog Number
- 0012691.000 FDA UDI
- Primary DI / UDI-DI
- B154R00126910000 FDA UDI
- 510(k) Number
- K971571 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
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
Category: Kidney donor-organ preservation/transport perfusion set
Dcm-100 Dual Kidney Cassette by Waters Medical Systems, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Kidney donor-organ preservation/transport perfusion set.
- LifePort® Kidney Transporter — Organ Recovery Systems, Inc. · Class II
- LifePort® Kidney Transporter — Organ Recovery Systems, Inc. · Class II
- LifePort® Kidney Transporter — Organ Recovery Systems, Inc. · Class II
- Perfusion Coupler — INSTITUT GEORGES LOPEZ · Class II
- LifePort® Kidney Transporter — Organ Recovery Systems, Inc. · Class II
- Perfusion Clamp with Adaptor — INSTITUT GEORGES LOPEZ · Class I
- LifePort® Kidney Transporter — Organ Recovery Systems, Inc. · Class II
- Kidney Assist Transport Perfusion set — XVIVO B.V. · Class II
Cleared under the same submission
K971571 also covers:
- Arterial Perfusion Occlusion Clamp — Waters Medical Systems, LLC
- CANNULA 10MM TEFLON STERILE - 1/packaging — Waters Medical Systems, LLC
- CANNULA 11MM TEFLON STERILE - 1/packaging — Waters Medical Systems, LLC
- CANNULA 12MM TEFLON STERILE - 1/packaging — Waters Medical Systems, LLC
- CANNULA 13MM TEFLON STERILE - 1/packaging — Waters Medical Systems, LLC
- CANNULA 14MM TEFLON STERILE - 1/packaging — Waters Medical Systems, LLC
- CANNULA 15MM TEFLON STERILE - 1/packaging — Waters Medical Systems, LLC
- CANNULA 16MM TEFLON STERILE - 1/packaging — Waters Medical Systems, LLC
- CANNULA 3MM TEFLON STERILE - 1/packaging — Waters Medical Systems, LLC
- CANNULA 4MM TEFLON STERILE - 1/packaging — Waters Medical Systems, LLC
- CANNULA 5MM TEFLON STERILE - 1/packaging — Waters Medical Systems, LLC
- CANNULA 6MM TEFLON STERILE - 1/packaging — Waters Medical Systems, LLC
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 ad7f8d59-ed95-495c-8c4e-b0ba5b415996 36 fields · synced Jun 9, 2026