GUDIDData
gudid Primary ID: R0059

Portex (UDI R0059)

Manufactured by ICU MEDICAL, INC.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Portex - Primary ID R0059

Device Regulatory Overview

The Portex (Model/Catalog Number: R0059) is a medical device manufactured by ICU MEDICAL, INC.. This product is indexed under FDA Product Code / Category Classification CAF within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
R0059
Product Code / EMDN
CAF
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
}
                            

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 Portex?

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

What is the Primary UDI-DI identifier for Portex?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is R0059.

What classification code is assigned to this device?

This device is registered under product classification code CAF.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint