gudid
Primary ID: 1
OxyTrainer ADVANTAGE (UDI 1)
Manufactured by D R BURTON HEALTHCARE, LLC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for OxyTrainer ADVANTAGE - Primary ID 1
Device Regulatory Overview
The OxyTrainer ADVANTAGE (Model/Catalog Number: 1) is a medical device manufactured by D R BURTON HEALTHCARE, LLC. This product is indexed under FDA Product Code / Category Classification ION within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 1
- Product Code / EMDN
- ION
- Device Name
- The OxyTrainer Advantage is a respiratory muscle trainer (RMT). It trains both inspiratory and expiratory muscles independently.
- Database Sync Date
- 2026-08-09 09:49:36
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of OxyTrainer ADVANTAGE?
The registered manufacturer of record for OxyTrainer ADVANTAGE is D R BURTON HEALTHCARE, LLC.
What is the Primary UDI-DI identifier for OxyTrainer ADVANTAGE?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1.
What classification code is assigned to this device?
This device is registered under product classification code ION.
Similar Classification Devices (ION)
Other Devices by D R BURTON HEALTHCARE, LLC
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