gudid
Primary ID: GMX30U-AIR/O2-P15
GENTEC (UDI GMX30U-AIR/O2-P15)
Manufactured by GENTEC(SHANGHAI)CORPORATION
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for GENTEC - Primary ID GMX30U-AIR/O2-P15
Device Regulatory Overview
The GENTEC (Model/Catalog Number: GMX30U-AIR/O2-P15) is a medical device manufactured by GENTEC(SHANGHAI)CORPORATION. This product is indexed under FDA Product Code / Category Classification BZR within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- GMX30U-AIR/O2-P15
- Product Code / EMDN
- BZR
- Device Name
- GMX Series Medical Air/Oxygen Blender is designed to dispense a continuous blend of Medical Air and Oxygen via outlet ports to infant, pediatric, and adult patients.
- Database Sync Date
- 2026-08-09 09:06:45
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 GENTEC?
The registered manufacturer of record for GENTEC is GENTEC(SHANGHAI)CORPORATION.
What is the Primary UDI-DI identifier for GENTEC?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is GMX30U-AIR/O2-P15.
What classification code is assigned to this device?
This device is registered under product classification code BZR.
Similar Classification Devices (BZR)
Other Devices by GENTEC(SHANGHAI)CORPORATION
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