Icon (UDI 395097)
Manufactured by Beckman Coulter, Inc.
Device Regulatory Overview
The Icon (Model/Catalog Number: 395097) is a medical device manufactured by Beckman Coulter, Inc.. This product is indexed under FDA Product Code / Category Classification JHI within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
Access Total T4 Calibrator, Catalog No. 33805...
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850...
MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative ...
Technical Specifications
- Model Number
- 395097
- Product Code / EMDN
- JHI
- Device Name
- Icon 20 HCG, Box of 25 Tests
- Database Sync Date
- 2026-08-09 09:22:51
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 Icon?
The registered manufacturer of record for Icon is Beckman Coulter, Inc..
What is the Primary UDI-DI identifier for Icon?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 395097.
What classification code is assigned to this device?
This device is registered under product classification code JHI.
Similar Classification Devices (JHI)
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint