eudamed_udi Primary ID: 00606959048232

System One Heated Humidifier IT (UDI 00606959048232)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The System One Heated Humidifier IT (Model/Catalog Number: IT6H) is a medical device manufactured by Respironics Inc.. This product is indexed under FDA Product Code / Category Classification R060201 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: IT6H
Product Code / EMDN: R060201
Device Name: System One Heated Humidifier
Database Sync Date: 2026-08-09 17:57:26

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 System One Heated Humidifier IT?

The registered manufacturer of record for System One Heated Humidifier IT is Respironics Inc..

What is the Primary UDI-DI identifier for System One Heated Humidifier IT?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00606959048232.

What classification code is assigned to this device?

This device is registered under product classification code R060201.

Similar Classification Devices (R060201)

Other Devices by Respironics Inc.

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