GUDIDData
gudid Primary ID: 53497

Welby (UDI 53497)

Manufactured by VERIDIAN HEALTHCARE LLC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Welby - Primary ID 53497

Device Regulatory Overview

The Welby (Model/Catalog Number: 53497) is a medical device manufactured by VERIDIAN HEALTHCARE LLC. This product is indexed under FDA Product Code / Category Classification DQA within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
53497
Product Code / EMDN
DQA
Device Name
Welby Pulse Oximeter
Database Sync Date
2026-08-09 09:11:41

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 Welby?

The registered manufacturer of record for Welby is VERIDIAN HEALTHCARE LLC.

What is the Primary UDI-DI identifier for Welby?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 53497.

What classification code is assigned to this device?

This device is registered under product classification code DQA.

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