gudid
Primary ID: 1
OxyPAP (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 OxyPAP - Primary ID 1
Device Regulatory Overview
The OxyPAP (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 BWF within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 1
- Product Code / EMDN
- BWF
- Device Name
- The OxyPAP is a positive airway pressure (PAP) therapy device which incorporates a positive end expiratory pressure (PEEP) valve and which also has the ability to deliver supplemental oxygen when used with compressed oxygen.
- Database Sync Date
- 2026-08-09 09:49:36
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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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of OxyPAP?
The registered manufacturer of record for OxyPAP is D R BURTON HEALTHCARE, LLC.
What is the Primary UDI-DI identifier for OxyPAP?
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 BWF.
Similar Classification Devices (BWF)
Other Devices by D R BURTON HEALTHCARE, LLC
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