gudid
Primary ID: 1
iPEP (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 iPEP - Primary ID 1
Device Regulatory Overview
The iPEP (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
- This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when the patient exhales through the device.
- 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 iPEP?
The registered manufacturer of record for iPEP is D R BURTON HEALTHCARE, LLC.
What is the Primary UDI-DI identifier for iPEP?
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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