GUDIDData
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gudid Primary ID: CSS01

Portrait CSS01 (UDI CSS01)

Manufactured by GE Medical Systems Information Technologies, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Portrait CSS01 - Primary ID CSS01

Device Regulatory Overview

The Portrait CSS01 (Model/Catalog Number: CSS01) is a medical device manufactured by GE Medical Systems Information Technologies, Inc.. This product is indexed under FDA Product Code / Category Classification MWI within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 2 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-0487-2018 View Full Alert →

GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to collect information ...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
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ID: Z-0202-2018 View Full Alert →

CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The PDM is i...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
CSS01
Product Code / EMDN
MWI
Device Name
PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.0.3
Database Sync Date
2026-08-09 09:14:30

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 Portrait CSS01?

The registered manufacturer of record for Portrait CSS01 is GE Medical Systems Information Technologies, Inc..

What is the Primary UDI-DI identifier for Portrait CSS01?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is CSS01.

What classification code is assigned to this device?

This device is registered under product classification code MWI.

Similar Classification Devices (MWI)

Other Devices by GE Medical Systems Information Technologies, Inc.

Programmatic Export

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