WAVES CONTROL UNIT

Basic Information

• Brand Name: WAVES CONTROL UNIT
• Primary DI: B154W39000420000
• Version / Model: WAVES CONTROL UNIT
• Catalog Number: 3900042.000
• Company Name: WATERS MEDICAL SYSTEMS, LLC
• Labeler DUNS: 556957871
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-12
• Public Version: 5
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: cad15d98-f40b-46d8-8373-11b76ee65029
• Distribution End Date: 2023-12-15

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDN	System, Perfusion, Kidney	Gastroenterology, Urology	876.5880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48039	Kidney donor-organ preservation/transport perfusion set	A collection of sterile devices intended to support and provide continuous physiologic organ perfusion to a donated kidney(s) during its preservation, evaluation, and transport in a kidney donor-organ preservation/transport system from the donor to the receiver hospital where the organ will be transplanted into the recipient. It typically includes a blood/fluid perfusion circuit, reservoir, pump, oxygenator, warmer, a urine collection reservoir, flow/pressure sensors, access and control valves, cannulae/connectors/tools to connect the appropriate vessels of the kidney and tubing lines, filters and bags to add/remove blood and solutions. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B154W39000420000	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K111521	000