GUDIDData
eudamed_udi Primary ID: 46923980110373

PV 5 Disposable Non - Rebreathing Valve (UDI 46923980110373)

Manufactured by GaleMed (Xiamen) Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for PV 5 Disposable Non - Rebreathing Valve - Primary ID 46923980110373

Device Regulatory Overview

The PV 5 Disposable Non - Rebreathing Valve (Model/Catalog Number: XTA0003) is a medical device manufactured by GaleMed (Xiamen) Co., Ltd.. This product is indexed under FDA Product Code / Category Classification R028001 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
XTA0003
Product Code / EMDN
R028001
Device Name
Disposable Valve & Manifold
Database Sync Date
2026-08-09 16:29:56

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 PV 5 Disposable Non - Rebreathing Valve?

The registered manufacturer of record for PV 5 Disposable Non - Rebreathing Valve is GaleMed (Xiamen) Co., Ltd..

What is the Primary UDI-DI identifier for PV 5 Disposable Non - Rebreathing Valve?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 46923980110373.

What classification code is assigned to this device?

This device is registered under product classification code R028001.

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