Waves Control Unit

FDA UDI

Class II (US FDA UDI)

by Waters Medical Systems, LLC

Identity

Trade Name: WAVES CONTROL UNIT FDA UDI
Generic Name: Kidney donor-organ preservation/transport perfusion set FDA UDI
Device Name: The WAVES “single kidney” machine perfusion device is a three-part system composed of a control unit, a disposable “WCM” cassette, and remote monitoring software. WMS designed the device with an ice/water backup system along with battery back-up power. These systems allow for transport or remote monitoring if customers decide this is necessary. Donor paperwork and typing materials, biopsy slides, and other specimens can be transported securely with the kidney using the system. The system provides optimal preservation while increasing the user’s ability to assess parameters. Our goal is to assist the OPO and transplant center by improving DGF rates and patient outcomes following transplantation. FDA UDI
Model / Reference: WAVES CONTROL UNIT FDA UDI
Description: The WAVES “single kidney” machine perfusion device is a three-part system composed of a control unit, a disposable “WCM” cassette, and remote monitoring software. WMS designed the device with an ice/water backup system along with battery back-up power. These systems allow for transport or remote monitoring if customers decide this is necessary. Donor paperwork and typing materials, biopsy slides, and other specimens can be transported securely with the kidney using the system. The system provides optimal preservation while increasing the user’s ability to assess parameters. Our goal is to assist the OPO and transplant center by improving DGF rates and patient outcomes following transplantation. FDA UDI

Identifiers

Catalog Number: 3900042.000 FDA UDI
Primary DI / UDI-DI: B154W39000420000 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Waves Control Unit 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 cad15d98-f40b-46d8-8373-11b76ee65029 37 fields · synced Jun 9, 2026