GUDIDData
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gudid Primary ID: V7.0

CardioSoft (UDI V7.0)

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 CardioSoft - Primary ID V7.0

Device Regulatory Overview

The CardioSoft (Model/Catalog Number: V7.0) is a medical device manufactured by GE Medical Systems Information Technologies, Inc.. This product is indexed under FDA Product Code / Category Classification DQK 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
V7.0
Product Code / EMDN
DQK
Device Name
CARDIOSOFT V7.0 SP7.2
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 CardioSoft?

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

What is the Primary UDI-DI identifier for CardioSoft?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is V7.0.

What classification code is assigned to this device?

This device is registered under product classification code DQK.

Similar Classification Devices (DQK)

Other Devices by GE Medical Systems Information Technologies, Inc.

Programmatic Export

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