Identity
- Trade Name
- Cannula 6mm SS, Non-Sterile FDA UDI
- Generic Name
- Kidney donor-organ preservation/transport perfusion set FDA UDI
- Device Name
- Cannula 6mm Stainless Steel, Non-Sterile FDA UDI
- Model / Reference
- 6mm SS FDA UDI
- Description
- Cannula 6mm Stainless Steel, Non-Sterile FDA UDI
Identifiers
- Catalog Number
- 3910142.006 FDA UDI
- Primary DI / UDI-DI
- B154R39101420060 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
No
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
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 6 Millimeter FDA UDI
Category: Kidney donor-organ preservation/transport perfusion set
Cannula 6mm SS, Non-Sterile 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 459ba7e6-37a5-4d00-bcc5-2bc67b1d9324 37 fields · synced Jun 9, 2026