gudid Primary ID: 7-N7905-I-MAN-P

Disposable Hyperinflation System (UDI 7-N7905-I-MAN-P)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Disposable Hyperinflation System (Model/Catalog Number: 7-N7905-I-MAN-P) is a medical device manufactured by WESTMED, INC.. This product is indexed under FDA Product Code / Category Classification BZR within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 7-N7905-I-MAN-P
Product Code / EMDN: BZR
Device Name: Hyperinflation, System, 1/2L Bag (Letx Free), 7' O2 and Manometer, Infant Mask, 40 CM pop off Valve
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 Disposable Hyperinflation System?

The registered manufacturer of record for Disposable Hyperinflation System is WESTMED, INC..

What is the Primary UDI-DI identifier for Disposable Hyperinflation System?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 7-N7905-I-MAN-P.

What classification code is assigned to this device?

This device is registered under product classification code BZR.

Similar Classification Devices (BZR)

Other Devices by WESTMED, INC.

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