GUDIDData
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eudamed_udi Primary ID: 00849111003407

Unspecified Brand (UDI 00849111003407)

Manufactured by ZOLL Circulation, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Unspecified Brand - Primary ID 00849111003407

Device Regulatory Overview

The Unspecified Brand (Model/Catalog Number: 8700-001070-02) is a medical device manufactured by ZOLL Circulation, Inc.. This product is indexed under FDA Product Code / Category Classification Z120304 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-1533-2025 View Full Alert →

Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0053-2022 View Full Alert →

Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), ...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0042-2022 View Full Alert →

ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabili...

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

Technical Specifications

Model Number
8700-001070-02
Product Code / EMDN
Z120304
Device Name
AutoPulse NXT Platform
Database Sync Date
2026-08-09 17:21:36

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 Unspecified Brand?

The registered manufacturer of record for Unspecified Brand is ZOLL Circulation, Inc..

What is the Primary UDI-DI identifier for Unspecified Brand?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00849111003407.

What classification code is assigned to this device?

This device is registered under product classification code Z120304.

Similar Classification Devices (Z120304)

Other Devices by ZOLL Circulation, Inc.

Programmatic Export

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