gudid
Primary ID: WCM Kit
WCM Kit (UDI WCM Kit)
Manufactured by WATERS MEDICAL SYSTEMS, LLC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for WCM Kit - Primary ID WCM Kit
Device Regulatory Overview
The WCM Kit (Model/Catalog Number: WCM Kit) 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 Kit
- Product Code / EMDN
- KDN
- Device Name
- DESCRIPTION The Waters WCM is primarily made of polycarbonate plastic. The pre-sterilized cassette contains a complete circulatory system (refer to diagram), designed for use on the Waters WAVES control unit. HOW SUPPLIED: The Waters WCM cassette is wrapped in a sterile wrap, sealed in a polyethylene bag, and is provided STERILE (ethylene oxide) fluid pathway. The Waters WCM cassette is intended for single-use only. CONTENTS: One (1) STERILE Waters WCM disposable cassette. One (1) STERILE Drape.Five (5) STERILE Specimen Tubes
- Database Sync Date
- 2026-08-09 09:43:54
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of WCM Kit?
The registered manufacturer of record for WCM Kit is WATERS MEDICAL SYSTEMS, LLC.
What is the Primary UDI-DI identifier for WCM Kit?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is WCM Kit.
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
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint