Identity
- Trade Name
- WAVES/WCM Sterile Drape FDA UDI
- Generic Name
- Kidney donor-organ preservation/transport perfusion set FDA UDI
- Device Name
- Sterile WCM drape. For use with WAVES/WCM perfusion control unit. FDA UDI
- Model / Reference
- DRAPE STERILE PACK - 1drape/bag (included in WCM cassettes kit) FDA UDI
- Description
- Sterile WCM drape. For use with WAVES/WCM perfusion control unit. FDA UDI
Identifiers
- Catalog Number
- 3910140.001 FDA UDI
- Primary DI / UDI-DI
- B154W39300050020 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
WAVES/WCM Sterile Drape by Waters Medical Systems, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 a510672f-5fec-40e6-899b-2883cc2699bc 37 fields · synced Jun 9, 2026