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enforcement Primary ID: Z-2343-2015

PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients. (UDI Z-2343-2015)

Manufactured by Draeger Medical, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients. - Primary ID Z-2343-2015

Device Regulatory Overview

The PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients. (Model/Catalog Number: Unspecified) is a medical device manufactured by Draeger Medical, Inc.. This product is indexed under FDA Product Code / Category Classification Catalog Number(s): 8416400, 8417400 within international Unique Device Identification (UDI) compliance databases.

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Technical Specifications

Model Number
N/A
Device Name
PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
Database Sync Date
2026-08-09 10:06:40

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 PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.?

The registered manufacturer of record for PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients. is Draeger Medical, Inc..

What is the Primary UDI-DI identifier for PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-2343-2015.

What classification code is assigned to this device?

This device is registered under product classification code Catalog Number(s): 8416400, 8417400.

Other Devices by Draeger Medical, Inc.

Programmatic Export

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