GUDIDData
eudamed_udi Primary ID: 00606959029323

System One Heated Humidifier GB (UDI 00606959029323)

Manufactured by Respironics Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for System One Heated Humidifier GB - Primary ID 00606959029323

Device Regulatory Overview

The System One Heated Humidifier GB (Model/Catalog Number: GB6H) 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
GB6H
Product Code / EMDN
R060201
Device Name
System One Heated Humidifier
Database Sync Date
2026-08-09 17:41:30

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 System One Heated Humidifier GB?

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

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

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00606959029323.

What classification code is assigned to this device?

This device is registered under product classification code R060201.

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