GUDIDData
gudid Primary ID: Adult Oxygenator + reservoir VKMO 70000-USA #SQUADR-i HMO70000+VHK710

QUADROX-i (UDI Adult Oxygenator + reservoir VKMO 70000-USA #SQUADR-i HMO70000+VHK710)

Manufactured by Maquet Cardiopulmonary AG

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for QUADROX-i - Primary ID Adult Oxygenator + reservoir VKMO 70000-USA #SQUADR-i HMO70000+VHK710

Device Regulatory Overview

The QUADROX-i (Model/Catalog Number: Adult Oxygenator + reservoir VKMO 70000-USA #SQUADR-i HMO70000+VHK710) is a medical device manufactured by Maquet Cardiopulmonary AG. This product is indexed under FDA Product Code / Category Classification DTN within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
Adult Oxygenator + reservoir VKMO 70000-USA #SQUADR-i HMO70000+VHK710
Product Code / EMDN
DTN
Device Name
QUADROX-i Adult HMO 70000 + VHK 71000 Oxygenator with venous hardshell cardiotomy reservoir, vacuum-tight
Database Sync Date
2026-08-09 09:11:49

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 QUADROX-i?

The registered manufacturer of record for QUADROX-i is Maquet Cardiopulmonary AG.

What is the Primary UDI-DI identifier for QUADROX-i?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Adult Oxygenator + reservoir VKMO 70000-USA #SQUADR-i HMO70000+VHK710.

What classification code is assigned to this device?

This device is registered under product classification code DTN.

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