gudid Primary ID: 3108-E

Adult Elongated Non-Rebreather Mask w/o Safety Valve (UDI 3108-E)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Adult Elongated Non-Rebreather Mask w/o Safety Valve (Model/Catalog Number: 3108-E) is a medical device manufactured by WESTMED, INC.. This product is indexed under FDA Product Code / Category Classification KGB within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 3108-E
Product Code / EMDN: KGB
Device Name: Adult Elongated Non-Rebreather Mask w/o Safety Valve, 7'Tube
Database Sync Date: 2026-08-09 09:04:13

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 Adult Elongated Non-Rebreather Mask w/o Safety Valve?

The registered manufacturer of record for Adult Elongated Non-Rebreather Mask w/o Safety Valve is WESTMED, INC..

What is the Primary UDI-DI identifier for Adult Elongated Non-Rebreather Mask w/o Safety Valve?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 3108-E.

What classification code is assigned to this device?

This device is registered under product classification code KGB.

Similar Classification Devices (KGB)

Other Devices by WESTMED, INC.

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