GUDIDData
emdn_classification Primary ID: Z12159002

AEROSOL EQUIPMENT (UDI Z12159002)

Manufactured by

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for AEROSOL EQUIPMENT - Primary ID Z12159002

Device Regulatory Overview

The AEROSOL EQUIPMENT (Model/Catalog Number: Unspecified) is a medical device manufactured by . This product is indexed under FDA Product Code / Category Classification Z12159002 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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🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-2755-2026 View Full Alert →

FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, I...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-2793-2026 View Full Alert →

SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System...

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

Technical Specifications

Model Number
N/A
Product Code / EMDN
Z12159002
Device Name
AEROSOL EQUIPMENT
Database Sync Date
2026-08-09 16:18:37

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 AEROSOL EQUIPMENT?

The registered manufacturer of record for AEROSOL EQUIPMENT is .

What is the Primary UDI-DI identifier for AEROSOL EQUIPMENT?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z12159002.

What classification code is assigned to this device?

This device is registered under product classification code Z12159002.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

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