gudid Primary ID: 900 000 628

AMBU Hyperinflation System (UDI 900 000 628)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The AMBU Hyperinflation System (Model/Catalog Number: 900 000 628) 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: 900 000 628
Product Code / EMDN: BZR
Device Name: Hyperinflation System, 1L Bag, 7' O2 and Manometer, 40 cm H2O Pop-Off Valve with Override
Database Sync Date: 2026-08-09 09:28:44

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 AMBU Hyperinflation System?

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

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

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 900 000 628.

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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