GUDIDData
gudid Primary ID: 452215

Jelco (UDI 452215)

Manufactured by ICU MEDICAL, INC.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Jelco - Primary ID 452215

Device Regulatory Overview

The Jelco (Model/Catalog Number: 452215) is a medical device manufactured by ICU MEDICAL, INC.. This product is indexed under FDA Product Code / Category Classification FMI within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
452215
Product Code / EMDN
FMI
Device Name
Database Sync Date
2026-08-09 09:20:08

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of Jelco?

The registered manufacturer of record for Jelco is ICU MEDICAL, INC..

What is the Primary UDI-DI identifier for Jelco?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 452215.

What classification code is assigned to this device?

This device is registered under product classification code FMI.

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