WCM Cassette (included in WCM cassettes kit) - 1/sterile bag (UDI WCM Cassette)
Manufactured by WATERS MEDICAL SYSTEMS, LLC
Device Regulatory Overview
The WCM Cassette (included in WCM cassettes kit) - 1/sterile bag (Model/Catalog Number: WCM Cassette) 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
- WCM Cassette
- Product Code / EMDN
- KDN
- Device Name
- The cassette is a self-contained circulation system consisting of an organ chamber, a venous and arterial reservoir, a bubble trap, a membrane oxygenator, a heat exchanger and pulsatile pump head. The system can provide circulation of one liter of PPS (machine perfusate) to one kidney. The kidney is attached to the arterial ports either in single fashion, or can be placed enbloc.
- 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 WCM Cassette (included in WCM cassettes kit) - 1/sterile bag?
The registered manufacturer of record for WCM Cassette (included in WCM cassettes kit) - 1/sterile bag is WATERS MEDICAL SYSTEMS, LLC.
What is the Primary UDI-DI identifier for WCM Cassette (included in WCM cassettes kit) - 1/sterile bag?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is WCM Cassette.
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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