gudid
Primary ID: WAVES CONTROL UNIT
WAVES CONTROL UNIT (UDI WAVES CONTROL UNIT)
Manufactured by WATERS MEDICAL SYSTEMS, LLC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for WAVES CONTROL UNIT - Primary ID WAVES CONTROL UNIT
Device Regulatory Overview
The WAVES CONTROL UNIT (Model/Catalog Number: WAVES CONTROL UNIT) is a medical device manufactured by WATERS MEDICAL SYSTEMS, LLC. This product is indexed under FDA Product Code / Category Classification KDN within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- WAVES CONTROL UNIT
- Product Code / EMDN
- KDN
- 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 users ability to assess parameters. Our goal is to assist the OPO and transplant center by improving DGF rates and patient outcomes following transplantation.
- Database Sync Date
- 2026-08-09 09:43:54
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of WAVES CONTROL UNIT?
The registered manufacturer of record for WAVES CONTROL UNIT is WATERS MEDICAL SYSTEMS, LLC.
What is the Primary UDI-DI identifier for WAVES CONTROL UNIT?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is WAVES CONTROL UNIT.
What classification code is assigned to this device?
This device is registered under product classification code KDN.
Similar Classification Devices (KDN)
Other Devices by WATERS MEDICAL SYSTEMS, LLC
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