gudid
Primary ID: 15-10-1309
EM (UDI 15-10-1309)
Manufactured by Allied Medical, LLC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for EM - Primary ID 15-10-1309
Device Regulatory Overview
The EM (Model/Catalog Number: 15-10-1309) is a medical device manufactured by Allied Medical, LLC. This product is indexed under FDA Product Code / Category Classification BYX within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 15-10-1309
- Product Code / EMDN
- BYX
- Device Name
- O2 SWIVEL FDISS X MDISS W/CK
- Database Sync Date
- 2026-08-09 09:00:32
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of EM?
The registered manufacturer of record for EM is Allied Medical, LLC.
What is the Primary UDI-DI identifier for EM?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 15-10-1309.
What classification code is assigned to this device?
This device is registered under product classification code BYX.
Similar Classification Devices (BYX)
Other Devices by Allied Medical, LLC
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint