Identity
- Trade Name
- RM3 Accessory Filter FDA UDI
- Generic Name
- Kidney donor-organ preservation/transport perfusion set FDA UDI
- Device Name
- RM3 Accessory Filter FDA UDI
- Model / Reference
- RM3 Accessory Filter FDA UDI
- Description
- RM3 Accessory Filter FDA UDI
Identifiers
- Catalog Number
- 3900056.001 FDA UDI
- Primary DI / UDI-DI
- B154R31800030050 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Kidney donor-organ preservation/transport perfusion set
RM3 Accessory Filter 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 4bab3154-0f55-4f67-97de-60f7847b50a5 36 fields · synced Jun 9, 2026