GUDIDData
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enforcement Primary ID: Z-0053-2022

Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305 (UDI Z-0053-2022)

Manufactured by ZOLL Circulation, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305 - Primary ID Z-0053-2022

Device Regulatory Overview

The Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305 (Model/Catalog Number: Unspecified) is a medical device manufactured by ZOLL Circulation, Inc.. This product is indexed under FDA Product Code / Category Classification All Lots within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2753-2026 View Full Alert →

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ID: Z-2755-2026 View Full Alert →

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ID: Z-2793-2026 View Full Alert →

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Technical Specifications

Model Number
N/A
Product Code / EMDN
All Lots
Device Name
Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305
Database Sync Date
2026-08-09 10:06:34

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 Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305?

The registered manufacturer of record for Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305 is ZOLL Circulation, Inc..

What is the Primary UDI-DI identifier for Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-0053-2022.

What classification code is assigned to this device?

This device is registered under product classification code All Lots.

Similar Classification Devices (All Lots)

Other Devices by ZOLL Circulation, Inc.

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