gudid
Primary ID: 4384
O3 (UDI 4384)
Manufactured by MASIMO CORPORATION
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for O3 - Primary ID 4384
Device Regulatory Overview
The O3 (Model/Catalog Number: 4384) is a medical device manufactured by MASIMO CORPORATION. This product is indexed under FDA Product Code / Category Classification MUD within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 4384
- Product Code / EMDN
- MUD
- Device Name
- O3 Sensor Infant/Neonatal Adhesive Sensor
- Database Sync Date
- 2026-08-09 09:59:04
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 O3?
The registered manufacturer of record for O3 is MASIMO CORPORATION.
What is the Primary UDI-DI identifier for O3?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 4384.
What classification code is assigned to this device?
This device is registered under product classification code MUD.
Similar Classification Devices (MUD)
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