gudid Primary ID: 12014

Drentech Bag - Replacement (UDI 12014)

Manufactured by REDAX SPA

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Drentech Bag - Replacement (Model/Catalog Number: 12014) is a medical device manufactured by REDAX SPA. This product is indexed under FDA Product Code / Category Classification GCY within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 12014
Product Code / EMDN: GCY
Device Name: Collection bag that can be connected with any gravity or active suction systems for collecting fluids from the patient.
Database Sync Date: 2026-08-09 09:04:33

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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Frequently Asked Questions

Who is the primary manufacturer of Drentech Bag - Replacement?

The registered manufacturer of record for Drentech Bag - Replacement is REDAX SPA.

What is the Primary UDI-DI identifier for Drentech Bag - Replacement?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 12014.

What classification code is assigned to this device?

This device is registered under product classification code GCY.

Similar Classification Devices (GCY)

Other Devices by REDAX SPA

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