gudid Primary ID: 7

MAC (UDI 7)

Manufactured by GE Medical Systems Information Technologies, Inc.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The MAC (Model/Catalog Number: 7) is a medical device manufactured by GE Medical Systems Information Technologies, Inc.. This product is indexed under FDA Product Code / Category Classification DPS 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

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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

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Technical Specifications

Model Number: 7
Product Code / EMDN: DPS
Device Name: MAC 7
Database Sync Date: 2026-08-09 09:14:30

Full Regulatory Attributes

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{
    "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 MAC?

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

What is the Primary UDI-DI identifier for MAC?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 7.

What classification code is assigned to this device?

This device is registered under product classification code DPS.

Similar Classification Devices (DPS)

Other Devices by GE Medical Systems Information Technologies, Inc.

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