GUDIDData
gudid Primary ID: GMX120U-AIR/O2

GENTEC (UDI GMX120U-AIR/O2)

Manufactured by GENTEC(SHANGHAI)CORPORATION

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for GENTEC - Primary ID GMX120U-AIR/O2

Device Regulatory Overview

The GENTEC (Model/Catalog Number: GMX120U-AIR/O2) is a medical device manufactured by GENTEC(SHANGHAI)CORPORATION. This product is indexed under FDA Product Code / Category Classification BZR within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
GMX120U-AIR/O2
Product Code / EMDN
BZR
Device Name
GMX Series Medical Air/Oxygen Blender is designed to dispense a continuous blend of Medical Air and Oxygen via outlet ports to infant, pediatric, and adult patients.
Database Sync Date
2026-08-09 09:06:45

Full Regulatory Attributes

🔒 Token Gated
{
    "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 GENTEC?

The registered manufacturer of record for GENTEC is GENTEC(SHANGHAI)CORPORATION.

What is the Primary UDI-DI identifier for GENTEC?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is GMX120U-AIR/O2.

What classification code is assigned to this device?

This device is registered under product classification code BZR.

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